Job Description

Our client is a global API development and manufacturing company expanding end-to-end CDMO services in the U.S.





Roles and Responsibilities:

  • Lead and manage the Quality Assurance and Quality Control teams at the site, as well as working with Global Regulatory Affairs for RA topics.
  • Ensure compliance with GMP regulations, global quality standards, and customer requirements for API manufacturing.
  • Oversee batch release activities, including review and approval of clinical and commercial GMP batches.
  • Develop, implement, and maintain Quality Systems (deviations, CAPA, change control, investigations, audits, etc.) to ensure a state of continuous compliance and inspection readiness.
  • Act as the primary quality contact for clients, regulatory authorities, and internal stakeholders for the site.
  • Support regulatory inspections and client audits; ensure timely and effective closure of observations.
    ...

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