Senior Manager, Quality Validation
About The Position
Revolution Medicines is seeking a Senior Manager, Quality Validation to provide quality oversight and operational leadership for validation activities across its external commercial manufacturing network. The role has primary responsibility for QA oversight of Process Performance Qualification (PPQ) and Continued Process Verification (CPV), along with other validation activities supporting commercial manufacturing, packaging, and product lifecycle management. The position also provides broader QA support across GMP operations and quality systems based on business needs. The role serves as the QA Validation representative for assigned commercial programs and external manufacturing sites, overseeing validation lifecycle activities and ensuring they are appropriately planned, executed, documented, and maintained. It reviews validation and process performance materials, evaluates CPV data and trends, and works with internal and external partners to address validation strategy, technical issues, and compliance risks. The Senior Manager also supports broader GMP quality activities, validation metrics, procedures, and inspection readiness.
Requirements
- Bachelor's degree in a scientific, engineering, or technical discipline.
- At least 8 years of pharmaceutical industry experience, including demonstrated experience in GMP Quality and commercial manufacturing operations.
- Demonstrated experience providing QA oversight of validation lifecycle activities, with strong experience in PPQ and CPV.
- Experience providing Quality oversight of CMOs and external partners supporting commercial manufacturing, packaging, testing, and validation activities.
- Strong knowledge of process validation lifecycle principles and applicable U.S. and global GMP regulations, regulatory guidance, and industry practices.
- Experience supporting commercial readiness, inspection readiness, and regulatory inspections, including domestic and international health authorities.
- Ability to critically evaluate complex technical and compliance issues, assess risk, and make sound, risk-based Quality decisions.
- Strong communication, collaboration, and stakeholder management skills, including the ability to work effectively with cross-functional teams and external partners.
- Ability to work independently, manage multiple priorities and aggressive timelines, and escalate significant quality and compliance risks effectively.
- Proficiency with electronic quality systems and Microsoft Office applications.
Nice To Haves
- Experience with packaging, cleaning, and transportation/shipping validation.
- Experience supporting validation and lifecycle management of commercial pharmaceutical products across multiple CMOs and external manufacturing partners.
- Experience with late-stage development, commercial launch, technology transfer, and post-approval lifecycle management activities.
- Experience with statistical trending and evaluation of CPV data, process performance, and continued process control.
- Experience working with oral solid dosage forms and associated manufacturing and packaging operations.
Responsibilities
- Provide QA oversight of validation activities at CMOs and external partners supporting commercial products, including Drug Substance, Drug Product Intermediates, Bulk Drug Product, Finished Product, and Packaged Product, with emphasis on PPQ and CPV.
- Serve as the QA Validation representative for assigned commercial programs and external manufacturing sites, overseeing validation lifecycle activities including PPQ, CPV, cleaning, packaging, and transportation/shipping validation.
- Review and approve validation plans, protocols, reports, risk assessments, process performance evaluations, investigations, and change controls.
- Review CPV data and process performance trends to confirm continued process control, identify emerging risks, and ensure appropriate investigation and escalation of adverse trends.
- Represent QA on cross-functional teams and partner with internal and external stakeholders on validation strategy, planning, technical issues, and compliance risks.
- Provide QA oversight and support for GMP quality activities, including deviations, investigations, CAPAs, change controls, specifications, master and executed batch records, validation documentation, and related quality systems.
- Establish, monitor, and communicate validation and process performance metrics, including PPQ/CPV status, trends, risks, and compliance issues; escalate significant concerns to Quality leadership.
- Lead or support development, periodic review, and revision of GMP procedures.
- Participate in inspection readiness, regulatory inspection support, and commercial readiness initiatives as needed.
- Build collaborative relationships with internal and external stakeholders to promote communication, teamwork, and effective execution.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
