Senior Manager, Quality Operations

Retro

$175K — $190K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5-7 years of experience in GMP Quality Assurance operations
  • Strong understanding of Quality Management Systems (QMS) and regulatory compliance
  • Experience with batch record review and drug product release processes
  • Proven ability to coordinate internal audits and support regulatory inspections
  • Strong communication skills for cross-functional collaboration
  • Hands-on experience with training and qualification programs

Responsibilities

  • Oversee day-to-day QA operations to ensure quality compliance in clinical manufacturing.
  • Maintain and improve the Quality Management System (QMS) with a practical approach.
  • Review batch records ensuring documentation is accurate and ready for inspections.
  • Coordinate QA release processes for clinical drug products in line with regulations.
  • Manage supplier and CDMO qualification processes to ensure quality standards are met.
  • Lead training programs to ensure compliance and operator qualifications are upheld.
  • Support internal and partner audits, ensuring thorough preparation and follow-up actions.

Benefits

  • Medical, dental, and vision insurance for employees and their families
  • 401(k) plan with 4% matching contributions
  • Flexible time off along with 10 company holidays annually
  • Paid parental leave for new parents
  • Annual learning and development stipend to encourage professional growth
  • Provided daily lunches and snacks for employees
Full Job Description
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:

  • 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:

  • 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:

  • 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.
  • >


$175,000 - $190,000 a year

At Retro, we don't use titles. New hires join as a "Member of X Team." Depending on experience, this role may align externally to the Manager or Senior Manager level in the broader biotech market.

Total compensation includes competitive base salary, generous equity, and benefits including:
  • Medical, dental, and vision insurance for you and your family
  • >
  • 401(k) plan with 4% matching
  • >
  • Flexible time off and 10 company holidays per year
  • >
  • Paid parental leave
  • >
  • Annual learning & development stipend
  • >
  • Daily Retro-sponsored lunch and snacks
  • >


We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert.

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