Senior Manager, Quality Validation

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The companys RAS(ON) inhibitors daraxonrasib (RMC-6236) a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291) a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805) a RAS(ON) G12D-selective inhibitor; and RMC-5127 a RAS(ON) G12V-selective inhibitor are currently in clinical development. As a new member of the Revolution Medicines team you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Revolution Medicines is seeking a Senior Manager Quality Validation who will play a key role within Quality Assurance providing quality oversight and operational leadership for validation activities across RevMeds external commercial manufacturing network. The role will have primary responsibility for QA oversight of Process Performance Qualification (PPQ) and Continued Process Verification (CPV) as well as other validation activities supporting commercial manufacturing packaging and product lifecycle addition to validation responsibilities this individual will provide broader QA support across GMP operations and quality systems based on business needs.

Responsibilities:

• Provide QA oversight of validation activities across CMOs and external partners supporting RevMed commercial products including Drug Substance (DS) Drug Product Intermediates (DPI) Bulk Drug Product (BDP) Finished Product (FP) and Packaged Product with primary emphasis on Process Performance Qualification (PPQ) and Continued Process Verification (CPV).

• Serve as the QA Validation representative for assigned commercial programs and external manufacturing sites providing oversight and approval of validation lifecycle activities including PPQ CPV cleaning packaging and transportation/shipping validation and ensuring activities are appropriately planned executed documented and maintained throughout the commercial product lifecycle.

• Provide QA review and approval of validation plans protocols reports risk assessments process performance evaluations and associated 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 to address validation strategy planning technical issues and compliance risks providing guidance consistent with current global regulatory requirements industry standards and best practices.

• Provide QA oversight and support for broader GMP Quality activities including deviations investigations CAPAs change controls specifications master and executed batch records validation documentation and other quality system activities supporting commercial manufacturing and product lifecycle management.

• Establish monitor and communicate validation and process performance metrics including PPQ/CPV status trends risks and compliance issues and escalate significant concerns to Quality leadership.

• Lead or support the development periodic review and revision of GMP procedures and participate in inspection readiness activities regulatory inspection support and other commercial readiness initiatives as needed.

• Build trusted collaborative relationships with internal and external stakeholders that promote open communication teamwork and effective execution.

Required Skills Experience and Education:

• A Bachelors degree in a scientific engineering or technical discipline is required.

• A minimum of 8 years of experience in the pharmaceutical industry demonstrated experience in GMP Quality and commercial manufacturing operations.

• Demonstrated experience providing QA oversight of validation lifecycle activities with strong experience in Process Performance Qualification (PPQ) and Continued Process Verification (CPV); experience with packaging cleaning and transportation/shipping validation is preferred.

• 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.

• Demonstrated 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 with the ability to effectively work with cross-functional teams and external partners.

• Ability to work independently manage multiple priorities and aggressive timelines and effectively escalate significant quality and compliance risks.

• Proficiency with electronic quality systems and Microsoft Office applications.

Preferred Skills:

• 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.

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