South San Francisco, California, United States
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)
Risk Based Audits & Vendor Oversight (Monthly / Quarterly)
Inspection Readiness & Regulatory Alignment (Project Based)
Mentorship & Quality Systems (Continuous)
Budget & Resource Planning
What Were Looking For
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.
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