Senior Manager, Clinical Quality Assurance

Pay Rate Low: 65 | Pay Rate High: 80

Our client is an innovative biotechnology research company focused on cardiovascular drug development , dedicated to advancing medicines that go beyond symptom management to help deliver meaningful, functional outcomes for patients.


Title: Senior Manager/Associate Director, Clinical Quality

Location: South San Francisco, CA

Schedule: Hybrid - Minimum 2 days onsite per week (If perm, 4 days onsite required)

Pay Rate: $65-$80/hour, with flexibility for the right candidate (benefits included)

Duration: 6-12 month contract with potential for hire


Position Overview


This is a hands-on role providing GCP quality oversight, risk management, audit and inspection support, and regulatory guidance while partnering closely with Clinical Operations and cross-functional teams.


Key Responsibilities

• Provide quality oversight for clinical studies , including protocol deviations, risk assessments, participant safety, and data integrity.
• Partner with Clinical Development, Clinical Operations, and study teams to ensure GCP compliance.
• Conduct and support internal and external GxP audits , including clinical investigator and vendor audits.
• Support audit and regulatory inspection readiness , including CAPA development and inspection activities.
• Support the Quality Management System (QMS) , including CAPAs, deviations, change control, risk management, quality complaints, and quality metrics.
• Monitor, trend, and assess GxP non-conformances, protocol deviations, and CAPAs .
• Interpret and apply FDA, ICH, GCP, GLP, and GVP regulations and guidelines .
• Review and contribute to the development and maintenance of SOPs, policies, and quality standards .
• Collaborate cross-functionally to promote a strong culture of quality and compliance across R&D.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred .
• Senior Manager: 8+ years of pharmaceutical or biotechnology industry experience, including 5+ years of GCP Quality Assurance experience.
• Strong knowledge of GCP Quality Management Systems, clinical trials, and drug development .
• Hands-on experience conducting clinical systems/process audits, clinical investigator site audits, and clinical vendor audits .
• Experience developing and maintaining SOPs .
• Strong understanding of FDA, ICH, and GCP regulations and guidelines ; GLP/GVP experience is a plus.
• Expertise in CAPA, root cause analysis, risk management, and quality oversight .
• Excellent communication, collaboration, organization, and problem-solving skills.
• Ability to work independently, manage priorities, and effectively collaborate with cross-functional stakeholders.

Preferred Qualifications

• Cardiovascular therapeutic area experience is a plus.
• Strong Phase II and Phase III clinical trial experience preferred.
• GLP and/or Phase I experience is a plus.
• Experience supporting regulatory inspections and global clinical development .
• Willingness to work onsite to support cross-functional collaboration, audits, and inspections .

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