CMC Quality Control Manager

3 weeks ago

San Francisco, United States GQR Full time

Job Overview:

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We are seeking a highly motivated and experienced Manager/Senior Manager to join our CMC Quality Control department. This role will oversee our external stability programs, supporting both commercial and clinical programs across all modalities and molecules. The successful candidate will work closely with internal QC representatives and external contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure quality standards are met. This is an exciting opportunity to join a biotech company dedicated to developing transformative therapeutics for patients with rare diseases.

Key Responsibilities:

  • Oversee quality control operational support across all assigned products/programs.
  • Support external contract organization activities to meet GMP QC testing needs.
  • Provide internal support to QC operations for the development, manufacture, and release of various products.
  • Ensure all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies.
  • Support the development and validation of analytical methods used for QC testing.
  • Implement and maintain quality systems to ensure the integrity and reliability of QC data.
  • Manage, review, and organize Release/stability data from active stability programs and generate interim stability trending assessments and reports.
  • Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines.
  • Address review comments on QC/analytical documents in collaboration with QA and other departments.
  • Manage document creations and reviews via Veeva Document System.
  • Initiate and manage change controls, deviations and CAPA in Veeva Document System.
  • Assist in OOE/OOS/OOT investigations and deviations.
  • Ensure compliance with current GMP’s in a manufacturing environment to support release and stability testing.

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