Senior Manager of Quality Operations

1 week ago


Raleigh, North Carolina, United States Jobot Full time
About the Role

We are seeking a highly experienced Senior Manager or Associate Director of Quality Operations to provide quality oversight for our biologics commercial programs. The ideal candidate will have a strong background in managing complex business relationships with QPs/EU business partners and expertise in drug product manufacturing.

Key Responsibilities
  • Ensure CMO compliance with applicable cGMP regulations, batch records, product registrations, quality agreements, and data integrity standards.
  • Support QA batch record reviews and lot dispositions of commercial drug substance and drug product per established procedures for internal and business partner use.
  • Lead quality aspects and provide support to our business partners on QA-related investigations, change controls, lot dispositions, and regulatory requests.
  • Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs).
  • Review and approve controlled documents, including commercial manufacturing and packaging master batch records, protocols, and final reports.
  • Work with our Quality Systems and CMC teams to ensure quality and technical documentation is delivered to the internal archiving system.
  • Provide guidance, advice, and support for GMP quality and compliance matters.
  • Represent Quality as PIP at CMO's as necessary to support production operations.
  • Demonstrate a high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
  • Contribute to development and improvement of our Quality System as relevant, such as creation and updating of SOPs.
  • Participate in developing, reporting, reviewing, and trending of GMP-related Quality Metrics such as Key Performance Indicators (KPIs) in support of the QMS.
Requirements
  • University degree in life sciences or related fields.
  • 5+ years' experience in GMP Quality in biopharma/biologics/pharmaceutical industry.
  • Experience working directly with contract manufacturing organizations (CMOs) is required.
  • Direct interaction with FDA, EMA, or other regulatory agencies during regulatory inspections and qualified persons (QPs) is required.
  • Experience in biologics is required.
  • Experience in sterile drug product manufacturing is preferred.
  • Thorough knowledge of cGMP regulations.
  • Experience supporting commercial and lifecycle management.
  • Experience in oversight of contract manufacturing.
  • Proficiency in electronic QMS Software such as Veeva, Trackwise, etc.
  • Excellent attention to detail, organizational, and time management skills.
  • Must have strong written and oral communication skills.


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