Sr. Manager/Associate Director GCP QA

Kennedy Bond; San Francisco (CA); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Kennedy Bond is seeking a Senior Manager or Associate Director, GCP QA to lead Clinical QA activities across programs in a hybrid Redwood City, CA setting. Working with the Director and QA team, you will shape the function as the clinical pipeline grows and ensure rigorous GCP compliance.

The role requires extensive QA leadership, regulatory-inspection experience, and the ability to mentor QA staff while driving risk-based audits and continuous quality improvements.

Qualifications

• 8+ years of clinical research or Clinical QA experience
• Strong GCP auditing and clinical quality-systems expertise
• Regulatory-inspection and inspection-readiness experience
• Experience with CRO oversight, deviations, CAPAs and investigations
• Ability to influence cross-functional clinical teams
• Leadership or mentoring experience appropriate to the level

Responsibilities

• Serve as the CQA lead for assigned clinical programs and study teams
• Provide GCP compliance oversight throughout the study lifecycle
• Develop risk-based audit plans and lead site, TMF, vendor and internal audits
• Lead inspection-readiness activities and support regulatory inspections
• Oversee deviations, CAPAs and critical quality investigations
• Support clinical risk management and critical-to-quality activities
• Improve the CQMS and develop SOPs and GCP training
• Mentor junior QA colleagues and, depending on level, oversee assigned team members

Job description

Senior Manager or Associate Director, GCP QA

Location: Redwood City, CA - hybrid, three days onsite

We are partnering with a profitable, commercial-stage biopharmaceutical company to appoint a Clinical Quality Assurance leader. The level is flexible based on experience. Working alongside the Director and wider QA team, this individual will lead Clinical QA activities across assigned programs while helping shape the function as the company’s clinical pipeline expands.

Responsibilities

• Serve as the CQA lead for assigned clinical programs and study teams
• Provide GCP compliance oversight throughout the study lifecycle
• Develop risk-based audit plans and lead site, TMF, vendor and internal audits
• Lead inspection-readiness activities and support regulatory inspections
• Oversee deviations, CAPAs and critical quality investigations
• Support clinical risk management and critical-to-quality activities
• Improve the CQMS and develop SOPs and GCP training
• Mentor junior QA colleagues and, depending on level, oversee assigned team members

Qualifications

• BA/BS in life sciences or a related field
• 8+ years of relevant clinical research or Clinical QA experience
• Strong GCP auditing and clinical quality-systems expertise
• Regulatory-inspection and inspection-readiness experience
• Experience with CRO oversight, deviations, CAPAs and investigations
• Ability to influence cross-functional clinical teams
• Leadership or mentoring experience appropriate to the level

The company offers competitive compensation and benefits.