Senior Analyst, Quality Assurance (Analytical)

About the Role

Reporting to the Associate Director, Quality – Analytical, the Senior Analyst is responsible for providing Quality Assurance oversight of internal and external Quality Control activities supporting Gene Therapy programs. This role ensures analytical testing, stability programs, and laboratory operations are conducted in compliance with cGMP regulations, global health authority guidelines, regulatory filings, and company procedures. You will serve as the primary QA point of contact for assigned products or laboratory functions, independently managing routine quality oversight and laboratory record approvals while escalating complex, high-risk, or strategic matters to QA leadership as appropriate. This position requires a strong quality mindset, technical understanding of analytical testing, and the ability to apply risk-based decision-making to maintain compliant, inspection-ready operations aligned with product lifecycle requirements.

What You'll Do

• Provide QA oversight of internal and external QC laboratory operations to ensure compliance with cGMP regulations and global health authority requirements.
• Serve as the QA point of contact for assigned products, stability programs, and/or laboratory functions.
• Review and approve release and stability analytical testing documentation, raw material qualifications, method validation protocols and reports, and equipment qualification documentation.
• Review and approve SOPs, deviations, investigations, CAPAs, change controls, and supplier notifications.
• Provide QA oversight of OOS, OOT, and atypical laboratory investigations to ensure scientifically sound root cause analysis and compliant documentation.
• Assess quality impact of laboratory events and escalate high-risk, cross-functional, or potentially regulatory-impacting issues to QA management as appropriate.
• Review and approve equipment qualification, calibration and maintenance program.
• Ensure compliance with data integrity requirements, including 21 CFR Part 11 and Annex 11.
• Ensure analytical methods and documentation remain aligned with regulatory filings and current product registrations.
• Track record status and analyze laboratory metrics and analytical trends to support compliance and continuous improvement.
• Review and approve internal and external analytical method qualification/validation.
• Participate in cross-functional discussions to provide quality input and risk-based recommendations.
• Support internal and external audits, regulatory inspections, and supplier-related quality activities as needed.
• Partner with QC to drive continuous improvement initiatives and maintain audit readiness.

Who You Are

• Minimum of a Bachelor's degree in Chemistry, Engineering, Life Sciences, or a related discipline.
• 5+ years of experience in Quality Assurance within the pharmaceutical or biotechnology industry, preferably supporting Quality Control operations.
• Experience supporting Gene Therapy and/or biologics experience, a must.
• Strong knowledge of cGMP regulations and global laboratory compliance standards (FDA, EMA, ICH).
• Experience with deviations, investigations, CAPAs, change controls, and method validation oversight.
• Working knowledge of data integrity principles and regulatory expectations, including electronic records and laboratory systems compliance.
• Familiarity with risk management tools (e.g., FMEA) and risk-based decision-making.
• Solid understanding of QC laboratory operations and analytical testing.
• Familiarity with analytical techniques such as HPLC/UPLC, CE-SDS, Cell Based Potency Assay, ddPCR, ELISA, Microbiology safety assay and related methodologies.
• Experience with quality and laboratory systems (e.g., Veeva, LIMS, Chromeleon, BMRAM or equivalent).
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Strong analytical thinking and sound judgment.
• Highly organized with strong attention to detail, accuracy, and clarity.

Where You'll Work

This role is based out of our San Diego office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

Travel Requirements

This role requires occasional travel (approximately up to 20%).