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Head of GMP Quality Assurance

2 months ago

Waltham Massachusetts, United States Deciphera Pharmaceuticals Full time
Position Overview

The Head of GMP Quality Assurance is responsible for ensuring adherence to regulatory standards, including 21 CFR 210/211, 312, EudraLex Vol. 4, and ICH guidelines. This role involves overseeing quality assurance processes and prioritizing quality-related tasks for both clinical and commercial partners.

Key Responsibilities
  • Ensure compliance with all relevant regulatory requirements.
  • Provide oversight and management of quality assurance initiatives.
  • Drive continuous improvements in quality assurance practices.
  • Lead and mentor the GMP QA team, fostering professional development.
  • Oversee the disposition of all materials.
  • Review and approve Master Batch Production & Packaging Records, as well as Executed Batch Production & Packaging Records.
  • Evaluate and approve analytical data, including release data, specifications, and stability studies.
  • Collaborate with internal teams and partners on validation and technology transfer efforts.
  • Establish and maintain strategic partnerships to achieve corporate objectives.
  • Support the internal audit program and prepare for regulatory inspections.
  • Lead activities related to Clinical QP release.
  • Review critical CMC sections of regulatory submissions.
  • Recruit and manage quality assurance personnel.

Qualifications

The ideal candidate will possess extensive experience in GMP quality assurance within the pharmaceutical industry, demonstrating a strong understanding of regulatory compliance and quality management systems. Strong leadership and communication skills are essential for success in this role.