Senior Manager, QA - Clinical

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.

Requirements

• 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

Benefits

• competitive medical, dental, and vision insurance
• mental health offerings
• equity incentive plan
• 401(k) program with employer match
• generous holiday and PTO policy