Senior Manager, Quality Operations
AI Summary
Senior quality leader responsible for day-to-day QA operations across clinical programs, maintaining the QMS, and ensuring compliant batch release, deviations, change controls, CAPAs, and audit readiness.
About this role
Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan.
We are building a mission-driven, collaborative team operating with speed, transparency, and adaptability.
We are hiring anew member of the team who will own day-to-day Quality Operations across Retro’s programs. In this role, you will own core QA operational processes, ensure the Quality Management System functions effectively as activity increases, and support compliant, phase-appropriate execution across clinical manufacturing and quality operations. You will work closely with internal teams and external partners to ensure quality processes are consistently applied and that clinical materials are reviewed, released, and managed in alignment with regulatory expectations. You will report to the Head of Quality and Analytical Development (Q&AD).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:
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Own and execute day-to-day QA operations across programs, supporting compliant clinical manufacturing and quality system activities.
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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.
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Support batch record review, particularly for internally manufactured products, and help ensure manufacturing documentation is complete, accurate, and inspection-ready.
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Perform or coordinate QA disposition and release of drug product for clinical use in alignment with internal procedures and regulatory expectations.
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Coordinate supplier, vendor, and CDMO qualification activities, including documentation, follow-up, and issue escalation.
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Oversee training programs, including training compliance, operator qualification, and aseptic technique qualification.
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Plan, coordinate, and support internal audits, including audit readiness, execution, and closure of follow-up actions.
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Support regulatory inspections and partner audits, including preparation, on-site support, and response development.
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Drive consistent application of quality processes and standards across programs, modalities, and operational teams.
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Partner cross-functionally with Manufacturing, MSAT, Process Development, Quality Control, and Analytical Development to proactively identify quality risks and implement timely mitigation strategies.
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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:
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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.
It’s a bonus if you have:
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Experience supporting GCP environments, including an understanding of clinical trial quality requirements and data integrity principles.
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Experience with aseptic manufacturing operations, including environmental monitoring, operator qualification, and contamination control strategies.
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Prior involvement in regulatory inspections, partner audits, or customer audits, including preparation and response activities.
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Experience with advanced therapy modalities (e.g., cell therapy, gene therapy, or other complex biologics).
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Experience in early-stage or rapidly scaling organizations, with exposure to building or evolving quality systems.
Skills
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