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Senior Manager/Associate Director, Quality Operations

1 month ago

Raleigh, North Carolina, United States Jobot Full time
Competitive Salary and Benefits Package

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

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.
  • Lead quality aspects and provide support to CMOs in QA-related investigations, change controls, documentation, 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.
  • Travel approximately 10% of time (domestic and international).

Qualifications:
  • 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.