דרושים Manager Operations Pmo ב-West Pharma ב-United States, Tempe

• 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

• Provide leadership defining the strategy in support of long-term and intermediate goals within Global Process Development in collaboration within the Global Contract Manufacturing and Technology Network.
• Develop scope of work, plan and manage for Injection Molding/Equipment Validation projects for the introduction of all new products into the company and compiling standard specifications for each process and monitoring all existing production to standard specifications.
• Use strong analytical skills to understand and implement customer/user needs, market requirements and other design inputs.
• Support CM Sales team in all new business quoting and gathering customer requirements relating to Process Engineering requirements.
• Identify, execute, and implement process improvement initiatives across the Global platform.
• Provide leadership/guidance on the installation and validation of new equipment/process development through SAT/IQ/OQ/PQ.
• Ensure that the procedures and systems are in place to facilitate the introduction of new processes and equipment.
• Drive idea creation, development, bread boarding/prototyping, feasibility testing, etc. to evaluate viability of ideas.
• Lead and advise component material selection with a strong emphasis on polymer selection for injection molded parts.
• Hands-on engineering, such as reverse engineering, simple assembly and machining work, component testing and failure analysis

• Provide continuity for the validation program for assigned plant or functional area by preparing technical documentation/presentations. Provide project leadership for materials / process related projects by coordinating the efforts of the various departmental disciplines for the successful completion according to plan and budget
• Managing internal and external resources to meet the technical requirements of the project, such as outside vendors, and management of techs and/or interns
• Work with Tooling Design team to plan innovative technical approaches to design solutions
• Coordinate engineering meetings with manufacturing plants. Identify, monitor status of results or projects.
• Leveraging internal and external resources to solving complex problems
• Help execute specific strategies, tactics and action plans for the location, as part of the overall Delivery Systems/Innovation product development plan, inclusive of management/ tracking of project activities and resources

• Bachelor's Degree in Engineering or another scientific area or equivalent experience required. Preferred Plastics
• Master's Degree in Engineering or another scientific area preferred

• Minimum 8 years in a similar position within the manufacturing industry required
• 3 years` experience in leading multifunctional teams of professionals globally required
• Good knowledge of LEAN and 6 sigma manufacturing principles (Green belt) required
• Good know-how and experience in Project management required
• Regulatory compliance in cGMP manufacturing and testing of Pharmaceutical or Medical Device Products.
• Ability to manage projects, teams, maintain timelines, and execute projects in a Global Engineering environment

• Expertise in injection molding techniques, methodology, and trouble-shooting methods; a deep understanding of equipment, process, and tools relating to injection molding
• Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
• Experience working with teams and influencing decisions
• Must have an in-depth knowledge of Statistical Process Control (SPC) and Design of experiments (DOE) and demonstrate use of same.
• Excellent understand of the Scientific approach to Injection Molding
• Preferred understanding of EDARTS, RJG Master Molder certificate
• Must have knowledge in computer systems; integrated manufacturing systems; word processing and spreadsheets
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
• Must be able to deal with all levels of employees and work across various departments.
• Experience in writing and executing validation protocols and reports,
• Ability to function as a team member.

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• 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

• Provide HR Leadership and direction for the site/multiple sites within your scope of responsibility.
• Supervise and provide guidance to direct reports.
• Approve hiring, firing and investment requests; and manage overall HR financial budget.
• Develop organizational objectives and facilitate goals creation for broader functions.
• Work with senior management and other peers for strategy development and execution plan.
• Guide the talent identification and development processes.
• Oversee employee performance and communicate goals results.
• Use in-depth expertise and experience to provide HR manager business partner support for various HR initiatives: performance and talent management, change management, workforce planning, leadership and employee development, onboarding and offboarding, compensation planning and benefits administration.
• Act as a trusted senior advisor to provides advice, clarification and follow-up on policies, procedures, benefits and compensation related items for employees, managers and global HR partners. Interprets and administers HR policies, procedures, guidelines and programs, always ensuring alignment with global West in a consistent manner.
• Perform other duties as assigned based on business needs.

• Bachelor's Degree in Business, HR or related field required
• Master's Degree in Business, HR or related field preferred

• Minimum 10+ years of experience in Human Resources and role of HR generalist and or HR manager required
• Deep experience and knowledge of multiple HR disciplines preferred
• Experience with HR business systems preferred

• Leadership.
• Change Management.
• Wide knowledge of federal and state employment law.
• Strong consultative, interpersonal and client orientation skills.
• Ability to work both independently and in a team environment.
• Capacity to handle confidential and sensitive information and issues in a discrete manner.
• Ability to work in a fast-paced virtual environment in a global organization.
• Trustworthy, inclusive, communication and presentation to diverse and large audiences, decision making, planning and organizing, personal accountability and attention to detail.
• Ability to prioritize and respond timely to changing requirements and to coordinate multiple tasks simultaneously.
• Knowledge of MS Office applications.
• 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 policies

• Human Resources\PHR or SHRM-CP Upon Hire preferred
• DDI certifications. Upon Hire preferred

• 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.
• Position operates in a professional office environment. May stand or sit for extended periods of time.
• This role routinely uses 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.

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Provide Quality oversight and direction for Quality Engineers.
• Provide direct supervision, resolves personnel issues, conducts performance evaluations and performs supervisory discipline as necessary.
• Recommend, evaluate, and implement process changes that are designed to continually improve the quality management system.
• Provide quality oversight, author, review, and/or approve site documentation (validation, change control, SOPs, WKIs, etc).
• Lead and manage QMS activities including CAPA, Failure Investigation, Non-Conformance assessment, audit findings, issue reviews, etc. Provide leadership and direct input on any nonconformance, deviation, or excursion that may occur and drive to closure.
• Direct involvement with FDA and ISO inspections and any external audits/assessments to ensure that the facility Quality Management System is properly represented. May act as lead for ISO and customer audits.
• Interface with customers for quality issues, technical information, specification, agreements, audits, etc.
• Recruit, train, develop, and lead staff to accomplish personal and organizational goals, adhere to policies/procedures and establish/maintain a ‘culture of quality’.

• Bachelor's Degree in Engineering or Science required and
• Chemistry or Engineering Degree preferred and
• Graduate degree preferred

• Minimum 8 years Minimum 8-10 years of experience required and
• Relevant work history and/or experience may be considered in lieu of degree and/or years of experience required and
• Previous experience with MasterControl, SAP, Share Point, Teamcenter preferred and
• Experience with ISO 13485 and 21CFR Part 820, 210, and/or 211 preferred

• Preferred previous experience with Master Control, SAP, SharePoint, Teamcenter
• Experience using Six Sigma and SPC tools and techniques
• Ability to use Excel, Word programs
• Must be able to operate and maintain office equipment (i.e. copy machines, multi-media, etc.).
• 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 at all times
• Able to comply with the company’s quality policy at all times.

• Engineering - General\ASQ Certified Quality Engineer (CQE or CQA) Upon Hire preferred and
• Manufacturing\Six Sigma Green Belt Certification Upon Hire preferred or
• Manufacturing\Lean Six Sigma Black Belt Upon Hire preferred

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Maintain high attention to detail, accuracy, and overall quality of work
• 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
• Effectively communicate and interface with various levels internally and with customers

Accountable for running the improvement, change and transformation activities generated by or impacting the Value Stream. Provides leadership coordination and oversight of activities across all departments/functions that support the Value Stream change goals and KPI’s. Ensures effective collaboration and performance of the Value Stream Management Team in support of the Change agenda while also protecting Operational delivery requirements. Reports directly to the Operations Manager. Coordinates and directs Change-dedicated resources as required.

• Assist in the development and organisation of plans for changes within the Value Stream. Identify opportunities for improvement and change within the Value Stream.
• Collaborate with cross-functional teams and key stakeholder to gather information on how changes will impact the work of the Value Stream and coordinate, schedule and organize these changes.
• Ensure operational readiness for the successful transition of programs from other functions to the Value Stream as agreed.
• Create comprehensive plans for change ensuring change readiness for implementation in the Value Stream, specifying the timing and estimated costs where applicable and support the assessment of the impact of proposed changes..
• Verify that the changes are safe and will not compromise operational safety. Quality and other regulator standards.
• Help design and or deliver communication plans to keep all Value Stream staff and other stakeholders informed about upcoming changes and how they will affect the run/work schedule.
• Support the Value Stream team in acquiring the knowledge and skills needed to adapt to changes effectively.
• Conduct implementation risk assessments for each change initiative and develop risk mitigation strategies with the VSLT to minimize disruption to production and quality. Keep track of how well changes are working and make adjustment plans accordingly.
• Ensure change performance measures/KPI’s align to site reporting requirements
• With the Operations Director and other Value Stream Leaders represent the change and transformation plans, strategies and needs of the Value Stream to other internal and external stakeholders, building the coalition of supporters and advocates to ensure the Value Stream’s success.

• Bachelor's Degree In project management, engineering, science, or business. required and
• Master's Degree preferred

• Minimum 8 years Project Management or Operations Management in process-based manufacturing required and
• Proven general leadership and production management experience which includes operational planning and analysis required and
• Experience working with ISO9000, FDA and cGMP required

• Change Management Skills: Possesses the ability to assist in developing and organizing detailed plans for changes within the Value Stream.
• Cross-Functional Collaboration: Skilled in working closely with cross-functional teams and key stakeholders and organize changes that impact the Value Stream.
• Operational Readiness Expertise: Capable of ensuring that the Value Stream is fully prepared for the seamless transition of programs from other functions, with a focus on maintaining operational efficiency.
• Comprehensive Planning Abilities: Proficient project/programme management capabilities
• Safety and Compliance Awareness: Demonstrates a strong understanding of safety and quality standards,
• Effective Communication Skills: Able to design and deliver clear communication plans
• Risk Assessment and Mitigation Skills: Experienced in conducting thorough risk assessments for change initiatives
• Performance Monitoring Competence: Proficient in monitoring the effectiveness of changes, with the ability to adjust plans as needed

• 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 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.