Senior Vice President of Quality Assurance

2 weeks ago


Pennsylvania, United States Medella Life Full time
Position Overview

The Vice President of Quality at Medella Life is responsible for ensuring the highest standards of quality across all operations. This role encompasses a variety of critical functions aimed at maintaining compliance and enhancing quality management systems.

Key Responsibilities
  • Quality Assurance Review: Conduct thorough QA evaluations of documentation and records, ensuring appropriate disposition of related products within CMC/Development, Clinical, and Commercial Operations.
  • Oversight of Third-Party Manufacturing: Provide quality management oversight for external manufacturing, packaging, and testing facilities.
  • Customer Complaint Investigations: Supervise the investigation processes for product complaints originating from Contract Manufacturing Organizations (CMOs).
  • Quality Management System Compliance: Ensure adherence to and continuous enhancement of the Quality Management System (QMS).
  • Site Visits: Travel to third-party sites as necessary to uphold quality standards.
  • Team Leadership: Manage and lead the Quality Team, fostering a culture of excellence and accountability.
Education and Experience Requirements
  • A Bachelor’s degree in a scientific discipline is required; a Master’s degree is preferred.
  • Over 10 years of experience in pharmaceutical and/or medical device sectors.
  • Proficient in providing pre-commercial quality support to Clinical, R&D/CMC, as well as quality assistance for Commercial Operations.
  • Experience with combination devices, integrating both pharmaceutical and medical device aspects.
  • Demonstrated history of collaboration with CMOs, CROs, CTLs, and business partners.
  • Experience in facilitating FDA inspections and managing back-room operations during such inspections.
  • Proficient in conducting compliance audits of third-party entities.
  • Familiarity with electronic Quality Management systems.


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