Senior Manager, Quality Operations

About you:

You are a practical, hands-on quality leader with deep experience in GMP Quality Assurance operations who enjoys making complex work run smoothly. You know how to build, run, and continuously improve the systems that keep quality execution on track—from document control and training to deviations, change controls, CAPAs, and batch review—while helping teams move quickly. You are just as comfortable in the details as you are stepping back to spot gaps, tighten processes, and keep work moving forward. You communicate clearly, work well across internal teams and external partners, and bring rigor, follow-through, and a low-ego, high-reliability approach to getting things done. You are motivated by the opportunity to help build quality operations that scale with Retro and support the development of therapies that extend healthy lifespan!

 

In this role, you will:

• Own and execute day-to-day QA operations across programs, supporting compliant clinical manufacturing and quality system activities.

• Own the maintenance, administration, and continuous improvement of the Quality Management System (QMS), including document control, training and qualification, deviation, change control, and CAPA workflows.

• Support batch record review, particularly for internally manufactured products, and help ensure manufacturing documentation is complete, accurate, and inspection-ready.

• Perform or coordinate QA disposition and release of drug product for clinical use in alignment with internal procedures and regulatory expectations.

• Coordinate supplier, vendor, and CDMO qualification activities, including documentation, follow-up, and issue escalation.

• Oversee training programs, including training compliance, operator qualification, and aseptic technique qualification.

• Plan, coordinate, and support internal audits, including audit readiness, execution, and closure of follow-up actions.

• Support regulatory inspections and partner audits, including preparation, on-site support, and response development.

• Drive consistent application of quality processes and standards across programs, modalities, and operational teams.

• Partner cross-functionally with Manufacturing, MSAT, Process Development, Quality Control, and Analytical Development to proactively identify quality risks and implement timely mitigation strategies.

• Lead and contribute to continuous improvement initiatives that enhance compliance, operational efficiency, and scalability of QA systems.

You will excel in this role if you have:

• 6+ years of progressive experience in Quality Assurance within a GMP-regulated biopharmaceutical environment, supporting clinical-stage development.

• Hands-on experience supporting clinical manufacturing operations, including batch record review, deviation management, investigations, CAPAs, and change control.

• Experience supporting qualification, oversight, and performance monitoring of suppliers, CDMOs, or CROs.

• Experience performing QA disposition and/or release of clinical drug product.

• Working knowledge of GMP regulations (e.g., FDA, EU, PIC/S) and phase-appropriate quality systems for clinical-stage products.

• Strong cross-functional collaboration skills.

• Demonstrate strong judgment in applying risk-based decision-making in a fast-paced, early clinical environment. 

• Communicate clearly and effectively across technical, operational, and quality stakeholders.

• Demonstrate strong attention to detail, documentation quality, and inspection readiness.

• A Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Engineering) or equivalent combination of education and experience.

It’s a bonus if you have:

• Experience supporting GCP environments, including an understanding of clinical trial quality requirements and data integrity principles.

• Experience with aseptic manufacturing operations, including environmental monitoring, operator qualification, and contamination control strategies.

• Prior involvement in regulatory inspections, partner audits, or customer audits, including preparation and response activities.

• Experience with advanced therapy modalities (e.g., cell therapy, gene therapy, or other complex biologics).

• Experience in early-stage or rapidly scaling organizations, with exposure to building or evolving quality systems.