Retro
Quality & Analytical Development
SeniorManager,QualityOperations
“Senior Manager, Quality Operations at Retro. Skills: Quality Operations, Quality Management System (QMS), continuous improvement, cross-functional collaboration. 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”
What You'll Achieve.
ensure the Quality Management System functions effectively as activity increases; support compliant, phase-appropriate execution across clinical manufacturing and quality operations; ensure quality processes are consistently applied; ensure clinical materials are reviewed, released, and managed in alignment with regulatory expectations; help teams move quickly; keep work moving forward; help build quality operations that scale with Retro; support the development of therapies that extend healthy lifespan; help ensure manufacturing documentation is complete, accurate, and inspection-ready; help ensure manufacturing documentation is complete, accurate, and inspection-ready; enhance compliance, operational efficiency, and scalability of QA systems
Industry & Context.
spot gaps; tighten processes; proactively identify quality risks and implement timely mitigation strategies
What They're Looking For.
Must Have
deep experience in GMP Quality Assurance operations, 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, comfortable in the details as you are stepping back to spot gaps, tighten processes, and keep work moving forward, communicate clearly, work well across internal teams and external partners, bring rigor, follow-through, and a low-ego, high-reliability approach to getting things done, motivated by the opportunity to help build quality operations that scale with Retro and support the development of therapies that extend healthy lifespan
Nice to 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
What You'll Do.
Own and execute day-to-day QA operations across programs
supporting compliant clinical manufacturing and quality system activities
and continuous improvement of the Quality Management System (QMS)
including document control
training and qualification
Support batch record review
particularly for internally manufactured products
and help ensure manufacturing documentation is complete
Perform or coordinate QA disposition and release of drug product for clinical use in alignment with internal procedures and regulatory expectations
and CDMO qualification activities
including documentation
Oversee training programs
including training compliance
operator qualification
and aseptic technique qualification
and support internal audits
including audit readiness
and closure of follow-up actions
Support regulatory inspections and partner audits
including preparation
and response development
Drive consistent application of quality processes and standards across programs
and operational teams
Partner cross-functionally with Manufacturing
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
How You'll Work.
Team & Collaboration
work well across internal teams and external partners; Partner cross-functionally with Manufacturing, MSAT, Process Development, Quality Control, and Analytical Development
Communication Scope
communicate clearly
Process & Methodology
process management, cross-functional coordination, resource planning
Applying for this Senior Manager, Quality Operations role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Lever
- Lever uses a streamlined one-page form — apply in under 5 minutes.
- LinkedIn import works well; review parsed data before submitting.
- The cover letter field is optional but visible to reviewers — use it to differentiate.
- Referral codes from employees can significantly boost visibility of your application.
ANONYMOUS · UNFILTERED
What do employees actually say about Retro?
Real rants from real employees. Read before you apply.