Senior Quality Operations Manager
Job Location:
Redwood City, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 a new member of the team who will own day-to-day Quality Operations across Retros 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).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 trackfrom document control and training to deviations change controls CAPAs and batch reviewwhile 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!
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.
Demonstrated success supporting Quality Assurance operations for clinical-stage small molecule products within a GMP-regulated environment (6 years preferred)
Hands-on experience supporting clinical manufacturing operations including batch record review product disposition and release investigations deviations CAPAs and change control.
Experience building implementing or continuously improving phase-appropriate Quality Management Systems that enable compliant scalable operations.
Experience partnering closely with internal scientific technical and operational teams to solve quality challenges in a collaborative risk-based manner.
Experience qualifying and overseeing CDMOs suppliers and other external manufacturing partners.
Strong working knowledge of FDA and international GMP regulations with the ability to apply them pragmatically in a fast-paced clinical-stage environment.
Sound judgment and attention to detail with the ability to balance compliance scientific rigor and operational efficiency.
A Bachelors degree in a scientific or technical discipline (e.g. Biology Chemistry Engineering) or an equivalent combination of education and experience.
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.
At Retro we dont 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
- Longevity 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. We are an equal opportunity employer; we do not discriminate based on race religion color national origin gender sexual orientation age marital status veteran status or disability status. We are diverse in background and singular in mission.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
Required Experience:
Manager
About Company
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. We are an equal opportunity employer; we do not discriminate on the basis of rac ... View more
