Program Manager Global Technology Transfers jobs at West Pharma in United States

Lead and manage Technology Transfers, that requires extended knowledge and relevant experience, referring to West sites and process capabilities, for the Global Sites as assigned to the timelines and objectives established. Independent work to ensure that all transfer risks are assessed and appropriate mitigation actions defined by TT team and West network experts. Enhancement of Transfer documentation templates and training of NetOp and site resources. Contribute to the TT team success managed by other leads.

• Propose and agree with NetOp QA TT execution strategy and TT scenario
• Works independently to manage technology transfer projects, globally, to the timelines and objectives established:
• TT projects high complexity, within a region
• Low and mid complexity TT projects between regions
• Manage each project encompassing all aspects of the transfer project (quality, items, customers, capacity, product strategy, transport, equipment, regulatory...)
• Work with Global QA NetOp to determine TT strategy and acceptance criteria.
• Lead and execute transfer projects using West Project Management Best Practices.
• Compiling and approval of a Project Charter, opening and closing of a Change Control
• Planning – priority, complexity, schedule, duration, required resources
• Execution – coordinate completion of all TT activities, documentation, production and testing of required batches
• Communication within West and with customers
• Active contribution in the transfer projects, as a member of a TT core team, managed by other transfer Project Managers
• Gathering and analyses of numerous required data (operation, manufacturing, quality) and information for TT Requirements plan.
• Independent preparation and completion of the Technology Transfer Risk Assessment and Risk Mitigation Plan
• Compiling and analyses of test results and providing appropriate recommendations
• Establish the operational parameters, CQA’s and acceptance criteria to be evaluated
• Guide the West resources on managing required PNR and deviation investigation
• Compiling, review and approval of Technology Transfer Equivalence Protocol (document defining documentation, references, test procedures and acceptance criteria
• Compiling, review and approval Technology Transfer Equivalence Protocol Summary Report and Customer Summary Report
• Manage review and approval of TT documents on time
• Compiling and approval of Technology Transfer Gap Assessment if required
• Ensure West global tooling experts do assessment of tools conditions and gain for their recommendation about which tools will be used for production of the TT batches.
• Manage knowledge transfer between a sending and receiving site.
• Takes a new perspective using existing solutions to recommend and apply continues improvement and optimization of transfer processes and documentation templates
• Training of less experienced NetOp colleagues

• Minimum: Master’s in Engineering or Applied Sciences

• Strong analytical, communication, and interpersonal skills.
• Robust West Pharmaceutical product / process knowledge incl. Master Control & West Quality Systems.
• Lean Six Sigma Green Belt & Minitab software
• Strong extended project management skills with the ability to deploy solutions in a global environment.
• Influence - ability to influence effectively across multiple functions and regions
• Driving execution - through determining action steps and milestones required to implement a specific business initiative; adjusts activities or timelines as circumstances warrant.
• Customer oriented mindset

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• According to the principles of health and safety at work (substantiated by the Safety Leadership Statement), the job holder is aware of his/her particular responsibility regarding work safety and acts accordingly at all times
• Able to comply with the company’s quality policy at all times.
• The job holder is aware of his/her special responsibility for quality according to the company’s quality policy and conducts his/her activities in accordance with the company quality policy at all times.
• The job holder respects all specifications arising from the cGMP requirements and from the specifications DIN ISO 15378 and DIN EN ISO 9001 as per its current state and also as it applies to any future amendments. Support and contribute in Lean Sigma programs and activities towards delivery of the set target.

• While performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and finger to operate office equipment (ie phones, computers, copies, etc.).
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• The ability to be able to lift and carry various items up to 40 pounds.
• The employee is occasionally exposed to wet and/or humid conditions and fumes or airborne particles.
• The employee occasionally works near moving mechanical parts and or equipment.
• The noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required at all times in the manufacturing work environment.
• Job requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading or writing, organization, problem solving, understand direction, supervise and speak publicly, etc.

In this On-Site role you will coordinate business unit lean savings, goals and objectives through the use of statistical techniques by planning, scheduling, and executing process projects. You will communicate project status, and define and shape strategic planning efforts, including critical goal and objective development that identifies and improves critical processes necessary to achieve annual targets, including waste reduction to drive technical and operational improvement.

• Participate in the development and support of the West Business System (WBS), with the goal of sustaining operational standards on the site.
• Create and manage strategic plans to eliminate waste within the business unit by utilizing lean processes, key performance indicators, metrics, cost savings, best demonstrated practices and enterprise resource management.
• Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications, by ensuring the consistent and uniform application of OPEX tools.
• Provide leadership on lean thinking and lean processes to ensure established goals and objectives are met and provide methods to monitor processes to assure they remain in control.
• Organize and/or assist in the training and guidance for lean champions and team members to develop and implement Lean action plans and transfer lean initiatives to other West plants.
• Sets up and/or participates in continuous improvement events related to establishing a process or process improvement.
• Ensure that workplace process improvements are visible, that savings are tracked, validated and posted.
• Review control charts/data generated from facility processes to assure they are in a state of statistical control.
• Manage capital and non-capital projects to improve capacity, quality, efficiency, utilization and safety at the lowest cost. Manage projects by maintaining project timelines and continuously evaluating actual project costs with budgeted costs so projects will be completed on budget and in a timely manner.
• Collaborate with QA and Engineering to set up and conduct capability studies, designed experiments, sampling programs, process validations, etc. to evaluate the manufacturing capability of products/ processes, and provide input, analysis and actions related to the data generated from these studies.
• Assists with facility/supplier audits and meetings, as required.
• Performs other duties as assigned based on business needs

• Bachelor's Degree in Business, Engineering, or recognized equivalent required

• Minimum 8 years experience as an Operational Excellence manager or equivalent required
• Minimum 5 years experience in a manufacturing/production environment, utilizing Lean Manufacturing Principles required

• Must have good interpersonal/leadership skills and be able to interface with all departments and team member levels.
• Must have excellent organizational, interpersonal and problem-solving skills and be able to interface with employees in all levels of the organization.
• Excellent computer skills required including SAP, all MS Office applications, Mini-tab and other statistical software programs.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Install and control adequate protection of confidential information and documentation. Ensure that key operational and essential documentation files kept on computer or otherwise are properly backed up at all times.
• Restrict access to confidential information as required.
• Work closely with other functions to maximize achievement through a cooperative environment
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy at all times
• The position holder is responsible to consider the safety and health of our employees when designing or improving our workplaces. As a leader he educates and trains our employees on the importance of safety and acts as a role model.
• Able to comply with the company’s quality policy at all times.
• The job holder respects all specifications arising from the cGMP requirements and from the specifications DIN ISO 15378, DIN EN ISO 9001 and DIN ISO 50.001 as per its current state and also as it applies to any future amendments

• Manufacturing\Lean Six Sigma Black Belt LSS Champion, LSS Green Belt or LSS Black Belt Upon Hire preferred

• Ensures effective employee relations. Provides employee coaching, development, and performance reviews. Administers the hiring, termination, and disciplinary process for technicians.
• Resolves employee issues through problem resolution.
• Responsible for ensuring applicable training and compliance associated with work area and products.
• Responsible for shift personnel scheduling and assignments, verbal communications and visual checks of all work activity for the duration of each assigned shift.
• Lead and mentor technician team to achieve site and department goals in a fast-paced environment.
• Routinely evaluate and review employee performance.
• Technical and hands-on automated equipment troubleshooting, repair, and improvements.
• Analyze data to drive improvements, determine prioritization, and identify opportunities.
• Lead and provide mentorship in root cause and corrective action (RCCA).
• Assess and perform/schedule technical training, including electromechanical systems, pneumatics, servos, PLCs, schematic reading/interpretation, new technology, etc.
• Assist engineering to develop design concepts for new automation.
• Provide engineering assistance to ensure machinery and processes are at an optimum level.
• Promote and support a Lean Manufacturing environment within the facility.
• Research new technologies and methodologies to use in the facility.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Conform with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual and predictable attendance.
• Perform other duties as assigned based on business needs.

• Education: Associate degreein Engineering or Science field

• Experience: 5-8 years of experience
• 2+ years of managerial or supervisory experience in manufacturing environment required.
• Knowledge of manufacturing processes, workflows, production equipment and industrial techniques.
• Must have effective problem solving and interpersonal skills.
• Some validation experience – computer systems, equipment and process required and

• Strong leadership skills and interpersonal skills to communicate with peers.
• Possess broad based knowledge to successfully troubleshoot, diagnose, and solve problems that relate to mechanical, electrical, and pneumatic systems.
• Experience in medical device industry or other regulated industry.
• Ability to remain calm while working under pressure.
• Demonstrate knowledge concerning general safety protocol and procedures.
• Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP, and ISO 9002.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy and quality policy at all times.

• Manufacturing\Lean Six Sigma Certification-IASSC or Agile preferred
• Program and Project Management\Certified Project Management Professional (PMP)-PMI Knowledge of Agile and Waterfall methodologies preferred

The incumbent will be a strong advocate of quality systems and quality culture with the drive, experience and knowledge to be able to provide mentorship and direction on best practices.

The position can be located at any West site and is not limited to Exton.

• Ensure success of assigned projects by overseeing all aspects of project planning, resourcing, communications, problem solving etc.
• Coordinate Quality Culture events and initiatives such as Quality Culture workshops, recognition programs, customer visits etc.
• Establish and lead cross-functional quality-related meetings to review and discuss performance, status and prompting necessary actions as required.
• Partner with L&D, HR and other relevant functions to drive improvements to employee onboarding and training.
• Partner and/or liaison with other West functional areas to drive optimization of processes and procedures and bring resolution to issues.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Report out on projects and initiatives to Executive and Senior Leadership as requested.
• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• All other duties as required.

• Bachelor's Degree or equivalent experience required
• Master's Degree preferred

• Minimum 8 years Quality or related experience required
• Experience in regulated industry such as pharmaceutical and medical device preferred
• Experience with SAP and MasterControl systems preferred

• Project Management skills, able to manage multiple projects across the globe
• Ability to to forsee potential problems and navigate challenges efficiently all while maintaining a strong focus on stakeholder requirements and project goals.
• Strong interpersonal skills and ability to communicate at all levels of the organization e.g. during Global townhalls etc.
• Ability to work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions
• Knowledge of cGMP, cGDP, relevant ISO standards and medical device/Pharma requirements
• Ability to adhere to all company safety and quality policies

• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of customer visits and business development related activities
• Position operates in a professional office environment. May stand or sit for extended periods of time
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems

• Supports the planning and executes compliance and privacy auditing and monitoring activities.
• Supports the daily Data Loss Prevention reviews and communications.
• Manages the day-to-day operations of the annual compliance auditing and monitoring plan.
• Initiates and coordinates corrective and preventive action for areas of noncompliance as identified in the periodic audits and/or through the reporting system.
• Supports the implementation of annual compliance risk assessments.
• Conducts monitoring of AI activities/plans, including but not limited to, support for timely and fulsome assessments of AI pilot/use case requests and supports the AI Steering Committee
• Manages the annual Due Diligence review for agents and distributors
• Supports the Business Compliance & Integrity Department with generating reports used to track and trend activities related to compliance.
• Periodically reviews and recommends updates to compliance policies, procedures and annual compliance auditing and monitoring plan to ensure relevance in providing guidance to management and employees.
• Identifies potential areas of compliance vulnerability and risk, facilitating corrective action plans for resolution.
• Remains abreast of relevant regulatory publications and settlements.
• Collaborates with Chief Compliance & Privacy Officer to develop effective compliance training programs to include new employee orientation, targeted education and ongoing education for management and employees.
  

• Monitors the compliance mailbox, answers questions, and troubleshoots problems for users by phone and email.
• Provides reports as directed and/or requested to the Chief Compliance & Privacy Officer on issues and concerns.
• Collaborates with Chief Compliance & Privacy Officer to develop periodic reports for senior management and the board.
• Assists with the promotion of a compliance culture for the organization.
• Undertake special projects and duties as identified or assigned.

Bachelor's Degree required

• 8-10 years of work experience with 4-7 years of healthcare industry related experience in compliance, operations, privacy, quality, training or applicable experience in pharmaceuticals or medical devices.
• Project Management certification preferred (or experience in lieu of)
• Familiarity with compliance, healthcare and privacy laws and regulations, including but not limited to: FCPA, Anti-Kickback, GDPR, PIPL, EU AI Act and other AI regulations

• Exceptional attention to detail, analytical, and statistical skills.
• Strong written and verbal communication skills.
• Strong organizational and project management skills.
• Strong technology skills including Excel and PowerPoint; and experience creating data analytics preferred.
• Ability to work with and maintain confidentiality of company and personnel data.
• Must be a self-motivated team player with proven ability to identify issues and manage priorities in a fast-paced environment with a bias for action and a strong sense of ownership.
• Must be able to meet deadlines and manage multiple priorities.
• Responsible for identifying system, data, or process improvements that increase efficiency, compliance, or reduce cost to the business.
• Makes recommendations to compliance leadership, develops and supports execution of plans to implement recommendations in conjunction with compliance management.
• Demonstrates an aptitude for critical thinking in complex situations and an ability to synthesize ambiguous data into concrete insights and other duties as assigned.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Able to comply with the company’s safety and quality policy at all times.
• Preferred experience as a compliance professional responsible for the development and implementation of risk assessments and monitoring and/or audit programs with working knowledge of DOJ’s & OIG’s guidance of an effective compliance program.
• Previous Anti-Kickback Statue compliance risk experience preferred.
• Previous people management experience preferred.
• Review and interpret healthcare compliance regulations, policies, procedures and corrective action plans.
• Ability to be flexible, manage a diverse and demanding workload with minimal supervision.
• Ability to work effectively within a team environment.
• Clear, concise and persuasive writing and presentation skills.
• Decisive and capable of exercising good judgment under pressure.
• Demonstrated ability to problem solve and manage unforeseen changes to plans.
• Excellent interpersonal skills and ability to work as a team player.

• Weekly staggered work schedule to support APAC and Europe

• Strategically develop production plans in coordination with the Regional Planner/s and direct plant personnel in the execution of the approved plans --- following their review and approval at the monthly Sales and Operations Planning (S&OP) meeting.
• Directs the teams that develop and executes production, inventory, and material plans.
• Adheres to monthly S&OP schedule in providing inputs & managing outputs and participates in all required production and supply chain/customer meetings.
• Collaborates with the regional planner & demand analyst to understand customer demand (inter-company included) and market drivers to facilitate a balancing of capacity (tool, machine and labor), inventory and delivery lead-time in the development of the production plan.
• Partners with the regional planner to aggregate the plant Master Production Schedule (MPS), incorporate forecast & market demand and develop a production plan (VOLUME).
• Implements and oversees vendor managed inventory (VMI) programs.
• Executes Rough Cut Capacity Planning (RCCP) for key resources (tools, machine, labor and material) to establish that the Production Plan is achievable and to recommend the need for additional resources.
• Works with the strategic supply planner to develop and maintain a program to manage raw material sourcing routine for an optimal balance between inventory, cash flow and transportation cost.
• Provides strategic direction and guidance in planning for conversations related to purchasing of raw materials.
• Manages the customer order cycle and communication between plants, headquarters and the customer.
• Monitors manufacturing lead times and delivery performance to assure targeted customer service levels are being achieved.
• Provides oversight and strategic leadership on slow moving and obsolete inventory.
• In the absence of packaged solutions, develops and implements PC/Microsoft based tools.
• Leads effective product transfer plans and supports database coordinator to ensure the integrity and accuracy of the ERP and MES data.
• Develops and manages the training, growth, development, and succession planning for the Supply Chain Department
• Support and contribute to Lean/Six Sigma programs and activities
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Performs other duties, as assigned based on business needs.

• Bachelor's Degree Supply Chain, Engineering, Finance, or Business required
• Master's Degree MBA preferred

Minimum 10 years (Sr Mgr)experience in operational management in the medical device/pharma/plastics injection industry,Prior manufacturing experience in an industrial /cGMP setting andExperience in lean manufacturing systems and costs savings programs which affect company financial and growth plans are Required.

• Manufacturing\Certified in Logistics, Transportation, and Distribution (CLTD)-APICS preferred
• Manufacturing\Certified in Production and Inventory Management (CPIM)-APICS preferred

• Able to sit and/or stand for extended periods
• Able to be able to lift and carry various items up to 40 pounds
• Able to climb stairs and ladders
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Must also be able to maintain confidentiality and resolve conflicts.
• Ability to make independent and sound judgments.
• Read and interpret data, information, and documents
• Analyze and solve problems and interpret situations
• Work under deadlines with constant interruptions

• Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.
• Direct reports include quality control supervisors.
• Leads and directs the Incoming Inspection, In-Process Inspection, and Batch Release teams with a positive and patient attitude.
• Maintains and instills in others a “quality at the source” mentality as it pertains to all aspects of manufacturing, including documentation, training, and other functions related to production.
• Maintains and instills in others an “immediate audit readiness” mentality so that records and actions are executed in a way that ensures their accuracy, legibility, and immediate retrievability.
• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.
• Schedule and prioritize quality inspection, testing, and batch record review and release to support Operations and release of product.
• Identifies and develops opportunities to improve existing processes and procedures
• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.
• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
• Manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished.
• Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non?Conformance Report is required.
• Manages the development of documentation and procedures during the qualification of new equipment/inspection methods.
• Exhibits regular, reliable, punctual and predictable attendance.
• Creates, prepares, implements and improves Quality Control KPIs metrics.
• Determines/sets Goals and Objectives for the Quality control organization and training programs for team's development purposes.
• Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.
• Ensures equipment is up to date on Preventive maintenance and calibration activities.
• Maintains the lab/area well organized with a 5S mindset.
• Other duties as assigned.

• Bachelor's Degree in Technical or Engineering or equivalent experience required

• Minimum 8 years in quality control required
• 3+ years of supervisory experience required

• Metrology Equipment experience
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety and quality policies at all times

• Certified Manager of Quality/Operational Excellence preferred

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary. Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites. If necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet. The ability to be able to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions is required.
• This job requires decision making based on data analysis
• Must be able to generate, express, and exchange new ideas
• Must be able to understand direction and adhere to established procedures
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems