Company

Director, Quality Assurance (GCP/GLP)

Burlington, MA, USA

ProtaGene is a world-leading analytic CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and Quality system driven analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021 GeneWerk’s unique capabilities in vector safety, integration site analysis, and bioinformatics were integrated into our platforms and service offerings, establishing ProtaGene. The organization operates over four sites in Europe and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.

Candidate Role: We are seeking a highly motivated Director Quality Assurance (GCP/GLP) for our US Site located in Burlington, MA. Reporting to the Senior Director of Global GCP/GLP Compliance and working closely with the CEO, this individual will play a key role in expanding and shaping ProtaGene’s US-based Quality department, in collaboration with the global QA team.

Key Responsibilities:

  • Drive expansion of the Quality Management System in the US, including certification and accreditation responsibilities.
  • Perform internal audits in accordance with GCLP, GCP and GLP guidelines.
  • Participate in audits from external organizations, customers, and regulatory agencies.
  • Oversee qualification of equipment, systems, and suppliers.
  • Organize and supervise employee training.
  • Create, revise, and review documents such as SOPs and work instructions.
  • Oversee CAPA, deviation, risk analysis and change control management.
  • Participate in training and quality related marketing activities.
  • Communicate with domestic and international pharmaceutical and life science customers/auditors.
  • Managing the quality assurance department in the US.
  • Interacting, reporting, and collaborating with global QA team.

Qualifications:

  • Minimum Bachelor of Science in biology, biotechnology, medicine, pharmacy, or comparable natural/biological sciences is required.
  • Minimum of 5-7 years working in quality assurance preferably in the field of biotechnology, pharmacy, or cell/gene therapy (3+ years in GCP/GLP required).
  • Experience participating in GLP inspections by the FDA is required.
  • Experience leading the accreditation/certification procedures for CAP/CLIA is advantageous.
  • Experience with computer-based system validation and cloud-based IT systems is an advantage.
  • Strong quality awareness and ability to apply quality knowledge in practical work.
  • Ability to manage and coordinate personnel, as well as organize and drive performance of the quality assurance system.
  • Integrity, commitment, and a motivated work ethic.
  • Ability to work in a team and independently.

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