דרושים ב-West Pharma ב-United States, Radnor Township

• Drive program delivery for programmatic aspects of due diligence through post-integration
• Build and communicate a common methodology for delivery/reporting across all workstreams
• Manage workstream accountability across the organization, including into the C-suite
• Maintain focus of workstream leads on key value-drivers aligned to the core deal thesis
• Lead the program execution of transaction integrations across all functions to ensure delivery in partnership with Corporate Development and other key stakeholders
• Participate in pipeline review to provide insight into future M&A integration delivery needs, budgeting, strategy, and resource planning to achieve successful outcomes
• Provide and maintain recurring reporting and score-carding of functional and business unit performance against plans of record and IMO Project Plans
• Applies lessons learned from prior deals to continuously improve due diligence and integration planning practices
• Work within Corporate Development to build due diligence services to provide targeted insights, experience-based observations, and EBITDA and cash improvement opportunities to guide investment determinations
• Provide proactive decision support to executives and team members
• Present data to senior stakeholders and serve as point-of-contact for integration leaders at entities being evaluated / acquired
• Mobilize the internal resources and external partners to ensure effective and timely delivery
• Other duties as assigned

• Bachelor's Degree in Finance or Business Administration or equivalent experience required
• Master's Degree preferred

• Minimum 8 years of relevant experience required
• 4-6+ years of consulting or project management experience, ideally with direct exposure to M&A and integration planning / management required

• Experience collaborating with cross-functional project teams.
• Exceptional interpersonal skills, communication capabilities and the ability to influence multiple stakeholders with competing / conflicting interests.
• Capable of organizing information succinctly and communicating to all levels of an organization.
• Experience multi-tasking to lead and execute multiple projects in parallel.
• Strong presentation skills and ability to present material and complex matters in a succinct and organized manner
• Ability to think critically in tactical and strategic dimensions simultaneously.
• Demonstrated ability to effectively work across various functions in order to ensure deliverables are met against required timelines.
• Ability to prioritize tasks in real time and exercise judgment in high-stakes environment.
• Ability to quickly establish credibility, trust and support with both internal and external constituents.
• Strong ability to communicate effectively with leaders at the most senior levels within the corporation.
• Ability to interface effectively with all levels and functions both inside and outside of the organization.
• Able to comply with the company’s safety and quality policies at all times.

• Position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. May need to stand or sit for extended periods of time
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger and reach with hands and arms
• 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, tight deadlines, problem solve, and prioritize
• Ability to make work independently and sound decision making
• Observe and interpret situations, analyze and solve problems

The HRIS Project Specialist has responsibility for supporting the delivery and execution of West’s HR Projects.

Portfolio Management

• Drive transparency of project workloads, commitments and expectations by managing reporting and dashboards out of the West Project Management system.
• Champion of the HR PMO processes and the agile methodology.
• Support departments with the setup and maintenance of projects within the West Project Management system.
• Build and maintain strong relationships with customers, business partners, resource managers, and other senior level executives.

Project Management

• Manage smaller projects as assigned by the HR PMO.
• Maintain the project related data and documents within the West Project Management System.
• Define, drive and manage change management and communications activities that support assigned projects.

Harmonization

• Work closely with HR leaders and stakeholders to standardize HR processes globally.
• Drive harmonization of different approaches across global locations
• Develop strategies to ensure consistency and efficiency in HR operations.

Training and Support

• Develop training materials and provide support to teams during process implementation.
• Ensure that team members understand and adhere to new processes.

Other duties as assigned.

• Bachelor's degree in Human Resources, Business Administration, or a related field or equivalent experience
• 3-5 years experience in Project Management, preferably in HR operations.

• Excellent analytical and problem-solving skills.
• Ability to work independently and collaboratively in a global, multicultural environment.
• Exceptional communication and interpersonal skills, with the ability to communicate effectively with colleagues across the company from SME to Management teams
• Self-motivated and dynamic individual who is able to challenge and influence others, develop and maintain collaborative working relations across HR and other functions at West
• Familiarity with HRIS (Human Resources Information System) platforms.
• Project management skills with the ability to manage multiple tasks and priorities.
• Proven experience in managing projects related to HR process improvement.
• Familiarity with Agile or other project management methodologies.
• Experience coordinating and leading cross-functional project teams.
• Ability to comply with the company’s safety and quality policy at all times.

• Must be able to travel up to 10% of the time

• Sedentary - exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & 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
• 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
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines

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

In this role, you will be the primary point of contact for all KRONOS-related inquiries. You will be responsible for providing comprehensive support and assistance across various administrative tasks to ensure accuracy, compliance, and efficiency. The role involves closely collaborating with HR managers, supervisors, and the payroll department to maintain precise and timely payroll processing. Additionally, you will participate actively in audits and system upgrades to enhance the overall effectiveness of the operations.

• Assist and support Kronos time and attendance system for sites.
• Help remediate issues related to time and attendance, including identification and correction of inaccurate records.
• Help troubleshoot Kronos issues with HR managers and supervisors.
• Interface with Exton Payroll Department.
• On a biweekly basis, assist in finalizing the Kronos data in preparation for payroll processing.
• Interface with contingency employee agencies for time-related support.
• Participate in audits to ensure legal and policy compliance.
• Provide Kronos training to managers and employees.
• Participate in testing of system upgrades and new software
• Assist in preparation of vacation payout calculations for terminated hourly employees
• Complete all Verification of Employment inquiries.
• Assist in review of data entry of hourly and agency employees in HR system.
• Serve as temporary backup other Kronos administrators.
• Assist in creating and maintaining Job Aides..
• Comply with government regulations and company policy
• Other duties as assigned

• High School or equivalent experience is required.
• 0 to 3 years of either HRIS or payroll system experience.

• Excellent communication and interpersonal skills
• Strong organizational and time management skills
• Detail Oriented
• Proficient in Excel
• 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

• Lead and direct E2E design and architecture for SAP implementations as well as leading/managing global SAP production support.
• Possesses solid understanding of overall vision and business needs and utilize specialized expertise in SAP Production Planning to collaborate with Quality and Operations to define detailed User Stories for Digital and Transformation (D&T) enablement of business needs. This includes interpreting any issues and recommending solutions or best practices.
• Utilizes knowledge of best practices to help define strategic direction, help determine business needs and design and deliver technical solutions to key stakeholders and in partner with Application and Infrastructure.
• Essential core member of agile sprint team(s) to configure and develop optimal technical solutions / features.
• Provide technical delivery of functionality to meet defined business requirements as described in User Stories.
• Provide system support and maintenance in alignment with standards and process set within the ERP Services Delivery model, West policies, and procedures as well as regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP.
• Create and maintain system lifecycle documents in accordance with West policies and procedures, including creation and maintenance of SOPs, SOIs and Job Aids.
• Work within and participate in the Change Control process.
• Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibit regular, reliable, punctual, and predictable attendance.
• Other duties as assigned

• Ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Spearhead the mapping of map business requirements to optimal technical solutions.
• People Management, Work distribution, Performance evaluation, Cross functional team coordination.
• Ability to drive and create outcomes that are tangible.
• Mentor and coach the team to perform their task successfully. Focus on team building and development.
• Create and maintain project charters and plans, capital requests, budgeting and project management in accordance with the Project and Portfolio Management process and West policies and procedures.
• Uses breadth of expertise to solve complex problems.
• Provide system support and maintenance in alignment with standards and process set within the ERP-SAP S4 Hana Services Delivery model, West policies and procedures as well as Regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP.

• Deep expertise, understanding and knowledge of SAP – system functionality and technical understanding of SAP S4HANA Production planning, Manufacturing, Quality and related areas ( PP, QM, EWM)
• Should have experience in integrating SAP S4HANA
• SAP S4 HANA knowledge required, ideally actively involved in implementation of production and Quality
• Ability to work autonomously in a fast-paced & complex environment with a self-motivated work ethic; utilize sound judgment with an ability to manage multiple priorities with a sense of urgency.
• 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
• People management experience

• Bachelor's Degree or equivalent experience in Computer Science or Information Systems required

• 8-10 years of related work experience Bachelor’s degree Computer Science, Information Systems, or other related field or equivalent experience.
• Preferred but not required: Agile & Scrum Certification, ITIL

The Principal, Quality Assurance, GMP role focuses on ensuring compliance with cGMP standards within the WSS laboratories by identifying gaps, developing solutions, and overseeing their implementation. Collaborating with key stakeholders, the position ensures all improvements align with global quality and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer system validation, audit trails, electronic signatures, and data storage and retention.

• Responsible to identify gaps, formulate solutions, and drive closure to achieve and maintain compliance with cGMP standards within the WSS laboratories.
• Partner with key stakeholders to ensure that identified improvements are aligned with strategic global quality and lab requirements.
• Provide expertise and guidance for regulatory and industry expectations in terms of data integrity requirements: computer system validation, audit trail, electronic signature, data storage and retention.
• Perform recurring laboratory audits of quality test methods and results per established West procedures to confirm they are globally harmonized with respect to data recording and documentation.
• Identify and implement meaningful metrics and KPI’s to measure and improve WSS laboratory compliance.
• Provide guidance to QA and WSS Lab during regulatory and client audits on issues related to Data Integrity and Computer System Validation (CSV).
• Actively engage with the laboratory team to drive the completion of investigations and manage backlog when necessary; regularly analyze data trends to implement improvements and ensure customer expectations are met through effective reporting and communication.
• Assist the QA Manager by ensuring WSS team members are trained in GMP-relevant topics and ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations.

• Bachelor’s Degree and/or Masters in Science Technology or Engineering.
• Master's Degree preferred

• 8 years of quality-related experience with preferred experience in pharmaceutical and/or medical device industry
• Expertise of cGMP requirements, ISO standards and FDA regulations

• Create multifaceted Laboratory procedures on GMP related topics such as data documentation, processes, documentation templates, etc., in alignment with global laboratory strategies.
• Perform Expert-Level GMP review and approval of global laboratory documentation, i.e. check for compliance of Lab Records to cGMP requirements related to the activities of the global SME group.
• Expertise of cGMP requirements, ISO standards, FDA regulations, and quality systems such as ISO 13485, ISO 9001, ISO 15378, 21 CFR 820, 21 CFR 11, ISO 14971
• Working knowledge of various analytical instruments software and integration with LabVantage LIMS, Waters Nugenesis SDMS and Waters Empower desired.
• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Thorough understanding of validation activities and risk management principles and techniques
• Fluent in English
• Excellent written and verbal communication skills
• Strong problem-solving and critical thinking skills
• Support and contribute to 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.

• Adaptable to changes in the work environment, able to 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 understand and adhere to established procedures, multi-task, work under time constraints, problem solve, and prioritize.
• Effectively communicate and interface with various levels internally and with clients.