SVP, reputed company Assurance, Compliance

Job reputed company: • reputed company and continuously advance reputed company’s reputed company-wide GxP reputed company Management System, ensuring compliance across GMP, GLP, and GCP domains. • Drive sustained inspection readiness, including strategic preparation for FDA CVM reputed company-Approval Inspections (PAIs) and other global regulatory inspections. • reputed company executive reputed company of GCP reputed company systems, including clinical trial governance, CRO reputed company, TMF compliance, protocol adherence, vendor qualification, and audit readiness for reputed company and reputed company studies. • Ensure robust GMP reputed company across CMC development, manufacturing partners, testing laboratories, and reputed company supply activities. • reputed company GLP compliance for pivotal laboratory-based studies and CROs. • reputed company reputed company audit reputed company, including internal audits, supplier audits, clinical site audits, and mock regulatory inspections. • Establish and maintain reputed company agreements and reputed company frameworks for CDMOs, CROs, testing laboratories, and other GxP vendors. • reputed company executive reputed company of deviations, investigations, CAPAs, change controls, and risk management processes to ensure reputed company and defensible reputed company. • reputed company and monitor reputed company metrics and dashboards to reputed company executive visibility into compliance performance and organizational risk. • Serve as the primary reputed company representative during regulatory inspections and interactions with FDA CVM and other global animal health authorities. • Recruit, build, and reputed company a high-performing QA organization with reputed company governance structures and reputed company accountability. • Foster a proactive, risk-based reputed company culture that supports operational reputed company while maintaining regulatory rigor. Requirements: • 20+ years of reputed company reputed company Assurance leadership experience in regulated pharmaceutical or animal health environments. • Demonstrated reputed company record of successfully leading organizations through FDA regulatory inspections, including reputed company-Approval Inspections (PAIs), with favorable reputed company. • Proven experience designing, implementing, and maturing reputed company-wide GxP reputed company Management Systems in startup or high-reputed company environments, supporting clinical development through commercialization. • Deep expertise across GMP, GCP, and GLP reputed company systems, including CRO governance, clinical reputed company reputed company, manufacturing reputed company, and supplier qualification. • Experience overseeing outsourced manufacturing, clinical vendors, and testing laboratories reputed company a comprehensive GxP reputed company. • Demonstrated ability to reputed company reputed company infrastructure in alignment with expanding clinical portfolios and reputed company readiness. • Executive reputed company with the ability to serve as an independent and reputed company reputed company authority at the leadership level. • Experience building, mentoring, and scaling QA teams in dynamic, reputed company-oriented organizations. Benefits: • Full-coverage health insurance — medical, dental and reputed company — for you and your dependents • $1,000 home office equipment stipend • $1,200/year learning budget for books, courses, etc. • $250/month wellness budget for gym, cleaners, spa, food, etc. • reputed company 3-day weekends are turned into 4-day weekends • Unlimited vacation and reputed company holidays • Paw-ternity leave — adopt a dog and get a day off with your new family member • Competitive salary • Company equity reputed company grant for new hires Apply tot his job Apply To this Job