Remote Director, Global Supplier Quality & Audit

Centessa Pharmaceuticals

Boston (MA)

On-site

USD 150,000 - 210,000

Full time

7 days ago
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Job summary

Centessa Pharmaceuticals, a remote US-based, clinical-stage company, seeks a Director of Supplier Quality, Inspection & Audit to lead and optimize supplier quality programs across GMP/GCP/GLP disciplines. The role reports to the Executive Director, GMP Quality Assurance within Product Quality, and oversees audits, CAPA, and inspection readiness.

The position requires 12+ years in pharmaceutical quality, BS/MS in Life Sciences, and extensive audit experience.

Qualifications

  • 12+ years pharmaceutical quality experience.
  • Extensive audit and inspection management experience.
  • Field auditing experience.
  • Knowledge of GMP, GCP, GDP, GVP, GLP, and CSA.

Responsibilities

  • Develop the strategy and tactically support the supplier quality program.
  • Manage and confirm robustness of the supplier qualification and monitoring programs.
  • Provide routine status updates/performance metrics on qualified suppliers.
  • Lead GMP, GCP, GLP, CSA and GVP supplier audit programs.
  • Develop annual audit plans and risk-based audit strategies.
  • Perform audits as required and review audit findings with CAPA closure.
  • Drive inspection readiness initiatives and related CAPA activities.
  • Collaborate with cross-functional teams on supplier performance.

Skills

Audit management
Inspection readiness
Regulatory knowledge
Field auditing

Education

BS/MS in Life Sciences or related field

Job description

Centessa Pharmaceuticals, a remote US-based, clinical-stage company, seeks a Director of Supplier Quality, Inspection & Audit to lead and optimize supplier quality programs across GMP/GCP/GLP disciplines. The role reports to the Executive Director, GMP Quality Assurance within Product Quality, and oversees audits, CAPA, and inspection readiness.

The position requires 12+ years in pharmaceutical quality, BS/MS in Life Sciences, and extensive audit experience.

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