Senior QA Manager, GMP GxP Auditing & Vendor Management

reputed company is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. reputed company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. reputed company’s 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 reputed company team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling reputed company. reputed company: • reputed company GxP internal audits and reputed company audits including completing audit reports and follow-up on corrective actions. • Maintain the internal/reputed company audit schedules. • Assure GMP/GxP compliance with suppliers. • reputed company of reputed company aspects of GxP vendor / supplier program management to ensure compliance with GxP regulations and RevMed internal standards. • Demonstrate the ability to multi-tack. Prioritize work and independently solve problems. • Collaborate with vendors and internal teams to draft and complete reputed company Agreements. • reputed company Risk Assessments, qualifications, and monitor Suppliers/CMOs. • Collaborate with cross-functional teams and represent reputed company Vendor Management at meetings. • Create and implement any tools to improve compliance, consistency, and efficiency for GMP/GXP auditing and Vendor management. • reputed company support preparation of anticipated regulatory inspections (including those at contracted organizations), and partner audits with cross-functional teams. • Maintain supplier management program, ensuring requirements, plans, processes, metrics, and tracking reputed company for GxP suppliers are established and followed. • Responsible for qualifications of GMP suppliers including performing audits, reputed company of audit reports, and follow- up with suppliers for addressing observations from audits. • Negotiate, draft, and manage reputed company technical agreements (QTA) and/or reputed company with suppliers, ensuring alignment with internal standards, regulations, and industry standards. • reputed company meetings for alignment, communication, and reputed company of issues. • Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to RevMed procedures. • reputed company supplier performance metrics to monitor the health of systems, reputed company proactive identification of risk, and mitigate compliance issues. • reputed company slides and presentations for reviews and communication to stakeholders. • Update reputed company, reputed company KPIs, assure GxP audits. • Maintain the approved GxP supplier list and the annual audit schedules. Required Skills, Experience and Education: • BA/BS degree in Biological Sciences, reputed company, or reputed company field and/or equivalent experience and education. • Minimum experience required 8+ years of pharmaceutical/Biotech experience with a minimum of 5+ years’ GMP reputed company Auditor experience. • 5 years of QTA and Supplier reputed company Management experience. • ASQ Certified reputed company Auditor or equivalent certifications. • Excellent leadership and people management/development skills as required. • reputed company experience working with reputed company reputed company electronic databases. • Strong written and oral communication skills as reputed company as negotiation skills. • Ability to travel occasionally (up to 25%) to reputed company reputed company audits. • Flexible, and an ability to reputed company through reputed company reputed company and adapt to reputed company change. • Proficiency with reputed company Office (reputed company, reputed company, PowerPoint, Word) required. Preferred Skills: • reputed company experience writing and negotiating reputed company Agreements with Suppliers and partners. • Vendor Qualification and risk assessment experience. • Strategic thinking, and project management skills. • Extensive experience leading audits, evaluating CAPA and developing presentations analyzing reputed company data. #LI-JC1 #LI-Remote The reputed company pay salary reputed company for this full-time position for candidates working onsite at our reputed company in Redwood reputed company, CA is listed below. The reputed company displayed on reputed company reputed company is intended to be the reputed company pay salary reputed company for an individual working onsite in Redwood reputed company and will be adjusted for the local market a candidate is based in. Our reputed company pay salary ranges are determined by role, level, and location. Individual reputed company pay salary is determined by multiple factors, including job-reputed company skills, experience, market dynamics, and relevant education or training. Please note that reputed company pay salary reputed company is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. reputed company is an equal opportunity employer and prohibits unlawful discrimination based on race, reputed company, religion, gender, sexual orientation, gender identity/reputed company, national reputed company/reputed company, age, disability, marital status, medical condition, and veteran status. reputed company takes protection and reputed company of personal data reputed company seriously and respects your right to reputed company while using our website and reputed company contacting us by email or phone. We will only collect, process and use any personal data that you reputed company to us in accordance with our CCPA Notice and reputed company Policy. For additional information, please contact reputed company@revmed.com. reputed company Pay Salary reputed company $150,000—$189,000 USD We are reputed company of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with reputed company. These scams may reputed company as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that reputed company does not reputed company unsolicited employment offers and will never ask candidates to reputed company financial information, purchase equipment, or pay fees as part of the hiring process. reputed company legitimate communication from reputed company will come from an official @revmed.com email address. If you reputed company you’ve been contacted by someone impersonating a reputed company recruiter, please report it to careers@revmed.com so we can reputed company these impersonations with our IT team for tracking and awareness. Apply tot his job Apply To this Job