Quality Assurance Manager

1 week ago


San Francisco, California, United States Meet Full time
Meet Our Team

We are seeking a highly skilled and experienced Quality Assurance Manager to join our team. Our ideal candidate will have a strong background in GMP regulations and industry standards, with a proven track record of ensuring compliance and quality in a biotech or pharmaceutical environment.

Key Responsibilities
  • Oversee and manage quality assurance activities to ensure compliance with GMP regulations and industry standards.
  • Review and approve batch records and ensure the accurate documentation of all production processes.
  • Handle and resolve commercial quality complaints, implementing corrective and preventive actions as needed.
  • Collaborate closely with quality control teams to ensure alignment with quality assurance practices.
  • Conduct internal audits and participate in external audits as required.
  • Provide guidance and training to team members on GMP practices and quality standards.
  • Develop and maintain quality assurance policies and procedures.
Qualifications
  • Bachelor's degree in a related field (e.g., Life Sciences, Chemistry, Engineering).
  • 7+ years of proven experience in a GMP quality assurance role within the biotech or pharmaceutical industry.
  • Solid experience with solid oral dosage forms and batch record review.
  • Demonstrated experience in managing or working within quality control environments.
  • Strong knowledge of regulatory requirements and industry standards.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and leadership abilities.


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