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West is seeking a Sr. Director of QA Design Quality & Risk Management to lead global quality compliance processes in the medical device and pharmaceutical industry. This hybrid role requires significant experience in regulated environments, along with strong leadership skills to manage cross-functional teams and drive quality initiatives.
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Job Summary
The Sr. Director of Design Quality and Risk Management serves as a key strategic partner to successfully drive harmonized, compliant, and effective product development processes across the enterprise.
This global role will partner with global sites and global cross functional teams including R&D, Regulatory, Operations, and Operations Quality to ensure a robust QMS infrastructure is in place which facilitates the development of safe, effective, and compliant products.
West Pharmaceutical Services is dedicated to improving patient lives and offers opportunities for lifelong learning, growth, and development, supported by comprehensive benefit programs.
Matching Summary
Match Score: 75
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West is seeking a Sr. Director of QA Design Quality & Risk Management to lead global quality compliance processes in the medical device and pharmaceutical industry. This hybrid role requires significant experience in regulated environments, along with strong leadership skills to manage cross-functional teams and drive quality initiatives.
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Skills & Requirements
Must-have
Design control and risk management processes
QMS integrity and effectiveness
Global harmonization of QMS
Product realization quality advocacy
Cross-functional team leadership
Nice-to-have
Continuous improvement initiatives
Talent development and mentorship
Lean QMS processes deployment
Adaptability to change
Key Requirements
Minimum 12 years experience in regulated Medical Device/Pharmaceutical industry
Experience with Medical Device Design & Development
Experience with medical device regulations (ISO 13485, ISO 14971, 21 CFR 820, EU MDR)
Bachelor's Degree in Engineering or Management/Leadership