Head of Quality Assurance

2 weeks ago

Amesbury, Massachusetts, United States Fraser Dove International Full time
Site Quality Head

Fraser Dove International is partnering with a leading pharmaceutical company to find a skilled Site Quality Head. This role is a key position in ensuring compliance with regulatory standards and developing robust quality systems.

Key Responsibilities:

  • Develop and implement quality systems aligned with industry standards and regulatory requirements.
  • Lead and mentor QA and QC teams to foster a culture of innovation and professionalism.
  • Engage with industry partners to address product quality matters and collaborate with cross-functional teams to meet customer needs.
  • Manage audits and regulatory inspections, providing strategic leadership and support.
  • Act as the primary quality expert, offering informed guidance to operations, research, and technology teams.
  • Optimize quality systems by developing and enhancing compliance-related manufacturing and process controls.
  • Assess and improve existing quality systems, aligning them with long-term organizational goals.
  • Design and implement targeted training programs to enhance quality staff competence and professionalism.

Requirements:

  • Bachelor's degree or higher in Life Sciences, Engineering, Quality Management, or a related field.
  • Extensive knowledge of GMP manufacturing and quality management for FDA or EMA-regulated products.
  • Proven experience in senior leadership positions within the industry.
  • Intermediate to advanced proficiency in quality assurance and/or quality control for cell and gene therapy.
  • Successful track record of developing, implementing, and managing quality programs aligned with GMP standards, corporate policies, and FDA/EMA regulations.

What We Offer:

  • Annual bonus
  • Relocation assistance
  • 401k
  • Healthcare
  • Dental Cover

Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. We take pride in helping exceptional life science organizations source the talent they need to design, manufacture, and distribute life-changing drugs, treatments, and devices that transform and save patient lives.

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