Job Details

The Quality Assurance team 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 We're Looking For

• Bachelor's 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