Clinical QA Leader: Vendor Oversight & GCP Compliance

Beam Therapeutics Inc.; Cambridge (MA); Sur place; USD 155 000 - 225 000; Plein temps

Résumé du poste

Beam Therapeutics Inc. in Cambridge, MA seeks an experienced Senior Manager / Associate Director of Clinical Quality Assurance to lead vendor qualification and ongoing oversight for CROs and clinical service providers, ensuring GCP compliance across studies.

This role partners cross-functionally to implement risk-based QA programs and drive inspection readiness. The ideal candidate has 7+ years in clinical/GCP quality, CRO/audit management experience, and strong knowledge of FDA/EMA/ICH

Qualifications

• 7+ years of clinical/GCP quality experience in a biotech or pharma setting.
• Experience qualifying and overseeing CROs and external vendors.
• Strong knowledge of FDA, EMA, MHRA and ICH guidelines.

Responsabilités

• Lead qualification and ongoing quality oversight of CROs and GCP/GCLP/GVP providers.
• Maintain risk-based vendor qualification and oversight framework with audits.
• Collaborate with study teams to ensure vendor quality oversight.
• Define audit strategy for external vendors and investigations with CAPA follow-up.
• Support enterprise-wide GCP inspection readiness and QA program evolution.

Connaissances

GCP quality

Vendor/Audit management

CRO oversight

Quality systems

Veeva experience

Formation

Bachelor's degree in life sciences

Outils

Veeva

Description du poste

Beam Therapeutics Inc. in Cambridge, MA seeks an experienced Senior Manager / Associate Director of Clinical Quality Assurance to lead vendor qualification and ongoing oversight for CROs and clinical service providers, ensuring GCP compliance across studies.

This role partners cross-functionally to implement risk-based QA programs and drive inspection readiness. The ideal candidate has 7+ years in clinical/GCP quality, CRO/audit management experience, and strong knowledge of FDA/EMA/ICH