Senior Director, Global GCP Quality Assurance

Centessa Pharmaceuticals; Boston (MA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

Wellness program

Job summary

Centessa Pharmaceuticals, a Boston-based clinical-stage company, seeks an Associate Director, Clinical Quality Assurance to oversee GCP QA for Centessa-sponsored trials from Early to Late Phase, ensuring compliance with global regulations and ICH guidelines.

You will lead QA programs, audits, CAPAs, and inspection readiness, partnering with cross-functional teams, and mentoring QA staff. Occasional travel is expected.

Qualifications

• BS or higher in Life Sciences, Chemistry, Pharmacy, or related field.
• 8–10 years of experience in pharmaceutical quality roles.
• Experience with document control software (e.g., ZenQMS, Veeva Vault, MasterControl) required.

Responsibilities

• Lead and maintain GCP QA programs, policies, and procedures.
• Serve as primary GCP QA expert and point of contact.
• Ensure clinical programs comply with global health authority regulations and ICH guidelines.
• Provide QA oversight for protocols, ICFs, CSRs, and other trial documents.
• Monitor evolving GCP regulations and communicate impact to stakeholders.
• Develop and execute global GCP audit strategies and annual plans.
• Conduct and manage audits of investigator sites, CROs, suppliers, systems, and documents.
• Prepare audit reports, evaluate CAPAs, and ensure effective follow-up.
• Lead inspection readiness activities and support regulatory inspections (e.g., FDA, EMA, MHRA).
• Partner with cross-functional teams to ensure compliance.
• Represent CQA on study teams and contribute to protocol design and risk management.
• Collaborate on procedures, forms, and templates related to clinical quality.
• Identify compliance risks and implement mitigation strategies.
• Investigate quality issues, perform root cause analyses, and drive CAPA resolution.
• Prepare and present KPIs, metrics, and audit status updates to leadership.
• Develop and maintain GCP-related SOPs, training materials, and quality metrics.
• Lead process improvement initiatives across QA and broader organization.
• Provide mentorship and leadership to QA staff; may include direct management

Skills

GCP QA

Quality assurance

Audit management

Regulatory compliance

Education

BS or higher in Life Sciences

Tools

ZenQMS

Veeva Vault

MasterControl

Job description

Centessa Pharmaceuticals, a Boston-based clinical-stage company, seeks an Associate Director, Clinical Quality Assurance to oversee GCP QA for Centessa-sponsored trials from Early to Late Phase, ensuring compliance with global regulations and ICH guidelines.

You will lead QA programs, audits, CAPAs, and inspection readiness, partnering with cross-functional teams, and mentoring QA staff. Occasional travel is expected.