Job Description

Our client is seeking a Senior Manager, Clinical Quality Assurance to play a key role in connecting clinical development timelines with essential regulatory and CGP requirements.

In this role, Quality is a proactive partner, not just a checkpoint. You will contribute to how clinical studies are designed, executed, and documented by applying your expertise in ICH‑GCP and risk-based, quality-by-design principles. As a core member of cross‑functional teams, including Clinical Sciences, Clinical Operations, and Regulatory Affairs, you will help ensure every study is conducted to the highest global standards.

If you enjoy collaborative problem‑solving, anticipating compliance risks before they surface, and guiding teams through complex international expectations, this role offers the opportunity to make a meaningful impact. You will help strengthen a culture where patient safety, data integrity, and operational excellence guide our decisions.

This position reports to the Associate Director, Quality Assurance – Clinical.

Responsibilities

As the Senior Manager, Clinical Quality Assurance, you will serve as a strategic partner and senior individual contributor responsible for strengthening the integrity of our clinical portfolio. You will drive proactive quality, risk-based oversight, and regulatory readiness across global studies through the following areas:

Strategic Study Leadership (Daily / Ongoing)

• Serve as the CQA representative on Study Execution Teams.
• Identify quality and compliance risks during protocol and study planning.
• Lead or support RCA discussions and recommend effective CAPAs.

Risk Based Audits & Vendor Oversight (Monthly / Quarterly)

• Plan and conduct investigator site, CRO, and internal process audits.
• Prepare clear audit reports that inform study and vendor decisions.
• Act as the quality point of contact for CRO partners and support ongoing governance.

Inspection Readiness & Regulatory Alignment (Project Based)

• Support mock inspections and global health authority readiness activities.
• Prepare SMEs for FDA, EMA, and other inspections.
• Monitor evolving ICH E6(R3)/GCP guidance and update procedures accordingly.

Mentorship & Quality Systems (Continuous)

• Provide technical guidance to junior team members, contractors, and third party auditors.
• Contribute to the development and optimization of Clinical and Quality SOPs and quality metrics.

Budget & Resource Planning

• Support QA leadership in planning audit resources based on study risk and geographic needs.

What Were Looking For

• Bachelors degree in life sciences or related field with 10+ years of industry experience, or an advanced degree with 7+ years of relevant experience
• 5+ years of direct experience in Clinical Quality Assurance or Clinical Compliance
• Proven experience leading Phase 1-III GCP audits and executing risk‑based audit plans
• Hands-on experience with QMS and eTMF systems (e.g., Veeva Vault)
• Strong ability to interpret ICH E6(R3) and 21 CFR Part 11 and translate them into practical quality strategies
• Demonstrated expertise in Root Cause Analysis (RCA) to development of sustainable CAPAs
• Comprehensive knowledge of global GCP regulations; recognized as subject matter resource for cross-functional teams
• Strong collaboration and communication skills; able to influence partners while upholding quality expectations
• Comfortable navigating ambiguity and applying sound judgment in complex clinical situations

Additional Valued Skills and Experiences:

While the following are desired, they are not required. We encourage you to apply even if you do not meet every qualification listed.

• Professional certifications such as RQAP‑GCP, ASQ‑CQA, Six Sigma.
• Experience supporting Nephrology or Small Molecule clinical programs.
• Prior experience in Clinical Operations
• Priority for candidates who can work Hybrid in San Francisco Bay Area