West Pharmaceutical Services · 10 hours ago
Sr. Director, QA Design Quality & Risk Management
US Pennsylvania Exton
Full-time
Hybrid
Director/Executive
12+ years expWest Pharmaceutical Services is a dedicated team focused on improving patient lives. The Sr. Director of Design Quality and Risk Management will drive compliant product development processes and oversee the integrity of the Quality Management System (QMS) across the enterprise, collaborating with global teams to ensure the development of safe and effective products.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
Responsibilities
Develop and manage a high-performing West Design Quality global team responsible for ensuring: Execution of defined business goals & objectives QMS processes which facilitate development of product which comply to applicable international quality and regulatory requirements
Partner with other Global Design Quality and Global R&D leaders to deploy strategic platform product development approaches to product development
Partner with other Global Design Quality and Global leaders to deploy harmonized, compliant, and scalable QMS solutions across the enterprise
Oversee and provide direction to cross-functional teams on design control and QMS elements including but not limited to change control, training, CAPAs, issue reviews, audit findings, investigations, risk management activities, document control, configuration control, and quality agreements
Establish, trend, and review KPIs and metrics with cross-functional leaders to drive improvements to the applicable elements of the QMS
Provide support in the creation of, resourcing for, and enforcement of development agreements for West proprietary products in collaboration with commercial, product management, R&D, regulatory, and operations
Understands customers’ requirements and needs during the development agreement stages to define a standard method for establishing, implementing, and enforcing customer agreements
Work closely with Global and site level Operations and Operations Quality regarding the interpretation and implementation of Design Controls and Risk Management to ensure smooth technical transfers into Operations
Ensure cross-functional teams collaborate across the enterprise. Communicate key messages, goals, and objectives to team members to drive alignment and a high-performance culture
Partner with other Design Quality leaders and Global Quality Systems leadership in developing and implementing lean QMS processes at the enterprise level. Lead and drive compliance to global harmonization initiatives and objectives
Direct a harmonized design control and risk management program globally within the enterprise with the support of Design Quality leadership. Proactively identify potential gaps and direct teams to resolve them. Lead continuous improvement initiatives to ‘challenge’ quality systems processes with respect to compliance / value add
Identify, develop, mentor, and lead Design QA talent to ensure the highest standard of Quality support is provided to R&D design, development teams, and SDC. Collaborate with leadership to identify succession plans
Forecast and ensure the appropriate level of Design QA staffing is maintained
Partner with organizational leaders and drive quality initiatives, systems, and methods to meet quality objectives. Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS
Oversee 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
Remain aware of developments in the quality field by reading current technical literature and attending technical meetings and/or industry conferences
Fill in for the Vice President of Corporate Quality as requested or required
Drive continuous quality improvement projects
Other duties as assigned
Qualification
Required
Bachelor's Degree Bachelor of Science in Engineering or Management/ Leadership required
Minimum 12 years of experience in regulated Medical Device and Pharmaceutical industry
Previous experience with Pharma containment and Drug delivery devices is a plus
Have previously led and managed the performance of multi-functional team(s) in Quality
Experience with Medical Device Design & Development, Verification / Validation Activities, Risk Management, Product Transfer, DHF Activities
Have experience in overseeing the design and development of medical devices in conformance with US FDA, CE Marking requirements, and/or similar regulatory approval routes
Experience with customer interface and meeting customer expectations
Experience using Six Sigma & SPC tools and techniques
Experience with medical device regulations (ISO 13485, ISO 14971, 21 CFR 820, EU GMP, and EU MDR)
Experience with Pharma Standards / regulations (FDA 21 CFR 210 & 211, ISO 15378, the EU GMP Annex 1)
Process Analysis /Certified Quality Process Analyst - ASQ ASQ or Industry Certification of Process Excellence
Preferred
Master's Degree Engineering or Business preferred
Understanding of requirements for initiating and managing Medical Device/Combination Device recalls, withdrawals, or other field actions with FDA, EU competent authorities and other Ministries of Health
Robust understanding, experience and execution of Root Cause Analyses, Investigations, CAPA, and Post-Market Surveillance (including reportability) in the Medical Device and/or combination device industry
Understanding of Computer System validation requirements for systems /platforms and for product firmware/software, as well electronic signature (21CFR part 11) requirements
Demonstrated leadership skills, including team building, employee development, and performance management and strong ability to develop rapport and partnership with customers and understand their product requirements
Excellent presentation, writing, verbal, computer, interpersonal and communication skills, including the ability to tailor messaging to all levels of the organization from the c-suite to manufacturing operators/QC inspectors
Ability to adapt to frequent changes, unexpected events and still yield an effective outcome, as well as manage competing demands, make timely and sound decisions, even under conditions of risk
Strong project management skills
Green or Black Belt certification
Previous experience with MasterControl, Veeva, SAP, Share Point, Teamcenter
Experience with ISO 60601, ISO 62366, ISO 11607 a plus
Other ASQ certification of CQE, CQA or CQM preferred
Benefits
Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.
Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration.
Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.
This position offers relocation assistance
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
H1B Sponsorship
West Pharmaceutical Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (24)
2023 (18)
2022 (26)
2021 (17)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
Chairman, President, and CEO
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2026-01-20
Company data provided by crunchbase