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Senior Director, Quality Assurance GCP

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Life Science Talent

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Location:
United States , Boston

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Senior Director, Quality Assurance GCP is a key role within Hemab's Quality function. Reporting to the Head of Quality, this individual will be responsible for creating and maintaining a robust GCP quality framework in close collaboration with Line functions. The role requires a seasoned quality professional who can operate strategically while remaining hands-on, partnering closely with line functions, internal clinical teams and external CRO and vendor partners to ensure inspection readiness throughout the clinical development lifecycle.

Job Responsibility:

  • Audit Planning and Execution
  • Quality Events Management
  • Support to Clinical Trial Teams
  • Inspection Readiness
  • Quality Working Group Participation
  • SOP Authorship and Approval
  • Building a Fit-for-Purpose Quality Organization

Requirements:

  • Advanced degree in life sciences, pharmacy, or a related field
  • Minimum 10 years of experience in GCP quality assurance within the pharmaceutical or biotechnology industry, with at least 3–5 years in a senior or leadership role
  • Demonstrated experience planning and conducting GCP audits across a range of audit types (CRO, site, vendor, systems)
  • Strong knowledge of ICH E6(R2/R3), EU Clinical Trial Regulation (536/2014), FDA GCP regulations, and related guidance documents
  • Experience working in an outsourced or virtual operating model, with a solid understanding of sponsor oversight responsibilities
  • Proven ability to manage regulatory inspections and lead inspection readiness programmes
  • Experience authoring and approving GCP SOPs and quality documentation
  • Excellent interpersonal and communication skills, with the ability to influence and partner across functions and with external stakeholders
  • Self-driven, pragmatic, and comfortable operating in a lean, fast-paced environment

Additional Information:

Job Posted:
May 03, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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