Senior Director, QA Design Quality & Risk Management
West Pharmaceutical Services
full-time
Posted on:
Location Type: Hybrid
Location: Exton • Pennsylvania • United States
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Job Level
About the role
- 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.
Requirements
- 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).
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
QMS processesdesign controlchange controlCAPAsrisk managementdocument controlconfiguration controlmedical device designverification activitiesvalidation activities
Soft Skills
leadershipteam managementcross-functional collaborationcustomer interfacecommunication
Certifications
ISO 13485ISO 1497121 CFR 820EU GMPEU MDRFDA 21 CFR 210FDA 21 CFR 211ISO 15378