דרושים United States, Whitpain Township

• Overall ownership and accountability for developing, leading and driving new business development for DDD OU product platforms for identified strategic accounts to achieve revenue growth targets for commercial and product development sales.
• Advance the vision for strategic partnerships and customer opportunities as the SME for device services offerings, for all direct assigned accounts and regions. Establish business development programs including early adopter customers, target service levels, and CDAs (Customer Development Agreements).
• Responsible for driving the prospecting and lead development, monitoring sales and funnel performance. Lead and support customer facing teams in key customer interactions/strategic partnerships throughout the selling journey including critical customer/strategic collaboration, presentations, post-sales leadership and problem solving to deliver on revenue and growth targets.

• Bachelor's in Engineering, Science or Business-related discipline

• Minimum 15 years of experience in B2B, Combination Products, Business Development, Product/Program Management.
• Indepth knowledge and experience in pharmaceutical/medical device technical development, sales, marketing or related business.
• Experience in successfully leading global multi-functional or cross-functional teams, in developing cohesive relationships and producing strong business results.
• Excellent communication/negotiation/influencing skills and strong customer focus.
• Excellent commercial and financial acumen.
• Self-starter, highly motivated and ability to work independently with little or no daily supervision.

• MBA or master’s degree preferred
• Background with a good technical understanding and knowledge of Combination products, medical device qualification, primary packaging, Regulatory requirements and Program Management.
• Significant leadership team experience and executive leadership exposure.

In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.

• Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
• Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
• Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
• Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
• Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
• Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
• Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
• May coordinate the activities of one or more exempt and/or non-exempt employees.
• All other duties as required.

• Bachelor's Degree in Science, Engineering or related field

• 8+ years of relevant work experience required

• 5+ years’ experience in pharmaceutical or medical device environment.
• 2+ years’ experience in a Quality role.
• ASQ CQE certification desirable.
• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
• Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
• Ability to manage direct report(s), work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Experience with SAP is preferred.
• 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.

• This position will join a team of transformation leaders to streamline processes and harmonize systems, while enhancing data governance across multiple platforms. The role collaborates closely with business units to align their objectives with West’s technology strategy, which focuses on enabling a secure and sustainable digital infrastructure. This involves eliminating the proliferation of disconnected technology deliveries and ensuring consistent, structured execution.
• As Director, Digital Business Integration for Corporate Functions (HR, Legal, HSE, Finance, and Corporate Development) , this leader will serve as a strategic partner and liaison; bridging business needs with technology solutions, while driving alignment, consensus, and adoption across global functions.

• Align business and technology strategies to enable faster, more effective deployment of digital solutions primarily for West's Corporate Functions.
• Standardize and harmonize processes and data across functions and regions, creating a single source of truth and significantly reducing operational complexity.
• Provide independent focus on optimization and efficiency , minimizing the impact of functional silos and avoiding day-to-day operational distractions.
• Enhance agility and responsiveness , enabling faster adaptation to organizational changes, market dynamics, and business needs.
• Shape and execute West’s digital strategy , ensuring alignment between enterprise transformation goals and the evolving technology landscape, while driving innovation in support of business priorities.
• Partner with leaders across HR, Legal, HSE, Finance, and Corporate Development to ensure technology investments deliver measurable value and are fully integrated into functional strategies.
• Act as a champion for process discipline, data governance, and risk management ; ensuring compliance with global standards while enabling flexibility for local needs.

• Manage a team of around five resources with expertise in digital finance, procurement, and human resources.

• Bachelor's degree in business administration, accounting, information systems, or related fields, or equivalent experience

• Minimum 10 years of experience in project execution, process design, and/or systems implementation
• Experience with SAP (S/4HANA preferred), specifically with Financial Accounting, Controlling, and Human Capital Management modules.
• Experience in the integration of SAP FICO module with HR Systems.
• Experienced business partner with a strong track record of collaboration with C-level executives

• Strong knowledge of and experience with leading practice budgeting, forecasting, analytics, and accounting principles for the typical business processes of a Life Sciences manufacturing company (Order to Cash, Procure to Pay, Record to Report, Hire to Retire, etc.).
• Ability to manage change effectively, including strong interpersonal communication skills that can be adapted to various levels of the organization.
• Experience with Agile project management framework, including setting goals, creating sprint plans, tracking progress, and holding teams accountable for timely delivery.
• Experience and/or training in Generative Artificial Intelligence and Machine Learning, SAP BW/BI, Microsoft Power BI, and other tools in the Microsoft Fabric Platform or similar tools for process automation.
• Ability to lead cross-functional teams collaboratively, encouraging resilience and maintaining a positive mindset.
• Comfort with ambiguity and the ability to logically structure issues and recommend best practice solutions.
• Mindset focused on continuous learning to maintain knowledge of industry trends, new technologies, and evolving best practices.
• Support the legal team’s IT needs, including compliance-focused solutions, secure document management, and data governance processes that strengthen risk management and audit readiness.
• Drive user adoption of digital tools and platforms by building strong partnerships with business stakeholders, promoting collaboration, and ensuring that solutions are practical, intuitive, and value driven.

• Use of written and oral communication skills
• Read and interpret data, information, and documents
• Observe and interpret situations, analyze and solve problems
• Ability to make independent and sound judgements
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, solve problems, and prioritize activities
• Position operates in a professional office environment. May sit or stand for extended periods of time
• This role routinely uses standard office equipment such as computers, phones, and photocopiers

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables.  In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

• Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
• Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
• Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Provide leadership to cross functional teams for regulatory issues and questions.
• Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
• Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
• Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required

• Bachelor’s degree or equivalent experience is required
• Master’s degree or PhD in science, math, engineering, or related discipline preferred

• Minimum 5 years of relevant experience
• 2+ years of medical device regulatory experience preferred
• Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
• History of successful international device registration,EU MDR technical documentation and/or US 510(K) authoring experience
• Advanced knowledge of ISO 13485
• Advanced knowledge of product life cycle, product development process, design control and change control
• Experience interacting with government agencies
• Excellent oral communication, technical writing, and decision-making skills

• Attention to detail with planning, time management and organizational skills
• Regulatory compliance competency including Quality Systems
• Experience with administration and safety systems preferred
• Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.

• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data.
• Ability to organize complex information and combine pieces of information to form general rules or conclusions.
• Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
• Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
• Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
• Ability to verbally communicate ideas and issues effectively to other team members and management.
• Ability to write and record data and information as required by procedures.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

• Direct and maintain the ERM program and strategy, ensuring alignment with Committee of Sponsoring Organizations' (COSO) ERM Framework and the latest professional standards, and publish/update ERM policies and procedures.
• Establish and lead an Enterprise Risk Governance Council and promote ERM activities and visibility within the Executive Leadership Team and across departments, operating units, and business functions.
• Provide expert risk consulting and advice to all levels of management and business units to ensure comprehensive, high-quality risk reporting and early identification of risk trends.
• Facilitate and coordinate requests for information from auditors, regulators, and collaborate with Financial, Legal, Compliance, Information Technology, Internal Audit, and Operations teams.
• Lead scheduled enterprise risk reporting and presentations for Executive Management, the Audit Committee, and the Board of Directors.
• Review key risk and performance indicators/metrics to assist in early risk trend identification and manage risk self-assessments with business unit management.
• Build strong internal and external alliances to positively influence risk identification and resolution.
• Provide risk support for major initiatives, including M&A activities, related integrations, vendor management projects, and large system/process improvements.
• Direct enterprise risk communication to stakeholders through targeted correspondence and internal networks and oversee the development and delivery of ongoing ERM training programs.
• Assure quality control of enterprise risk-related databases and risk registers and facilitate development and maintenance of department-level risk registers and dashboards in company databases.

• Master's Degree Business Administration, Finance, Accounting, or related field. preferred
• Bachelor's Degree Business Administration, Finance, Accounting, or related field. required

• Minimum 10 years of experience in enterprise risk management, audit, project management, or related field, including 5-7+ years in ERM process development and operation required

• Strong knowledge of COSO ERM framework and other internal control standards.
• Proficiency in risk quantification methods and systems.
• Ability to maintain ERM training and certifications to leverage current experience and enhance the ERM program.
• Strong interpersonal skills with the ability to build relationships across all levels of the organization, including the Board of Directors.
• Consistently demonstrate high standards, professional ethics, integrity, and trust.
• Positive and resourceful with an inquisitive nature, proactively seeking out information to drive successful ERM initiatives.
• Must be able to operate across different geographic time zones.
• Excellent communication and influence skills, including report writing, presentations, and group facilitation.
• Demonstrated executive presence and ability to work independently in a dynamic environment.