Senior Director, Global Clinical QA & GCP Compliance

Regulatory Jobs; Boston (MA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Discretionary annual bonus

401(k) plan

Medical, dental, vision and life 보험

Generous paid time off

Health and wellness program

Job summary

Centessa Pharmaceuticals in Boston, MA, is seeking an Associate Director, Clinical Quality Assurance (CQA) to oversee GCP QA across Centessa-sponsored trials from Early to Late Phase. This role ensures compliance with ICH, global regulations, Centessa SOPs, and inspection readiness.

The successful candidate will lead QA programs, audits of sites and vendors, manage CAPAs, and partner with cross-functional teams to maintain high-quality trial documentation and risk management.

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

Regulatory compliance

Audit management

CAPA management

Cross-functional collaboration

Education

BS or higher in Life Sciences

Tools

ZenQMS

Veeva Vault

MasterControl

Job description

Centessa Pharmaceuticals in Boston, MA, is seeking an Associate Director, Clinical Quality Assurance (CQA) to oversee GCP QA across Centessa-sponsored trials from Early to Late Phase. This role ensures compliance with ICH, global regulations, Centessa SOPs, and inspection readiness.

The successful candidate will lead QA programs, audits of sites and vendors, manage CAPAs, and partner with cross-functional teams to maintain high-quality trial documentation and risk management.