Senior Manager, Regulatory Compliance

5 days ago


Bothell, Washington, United States Tbwa ChiatDay Inc Full time
Key Responsibilities

We are seeking a highly skilled Senior Manager/Associate Director, Quality Assurance to join our team. In this role, you will be responsible for ensuring the quality and regulatory compliance of our Small Molecule and Antibody Drug Conjugate (ADC) portfolio.

You will work closely with the Contract Manufacturing Organization (CMO) to release Intermediate/RSM, drug substance, drug product, and finished drug product. Your primary focus will be on overseeing the batch record review, change controls, deviations, CAPAs, and other aspects of QA operations associated with batch release.

The ideal candidate will have a strong background in quality assurance and regulatory compliance, with experience working with CMO/CDMO partners.

  • Ensure quality and regulatory compliance throughout the different manufacturing stages.
  • Develop and implement quality procedures to ensure compliance with regulations and industry standards.
  • Collaborate with cross-functional teams to ensure quality and regulatory compliance.
  • Review and approve records/documents including validation protocols and reports, transfer documents, change controls, deviations, CAPAs, product specifications, technical reports, stability protocols, product complaints, and temperature excursion related documentation.


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