Senior Manager/Associate Director, Supplier and Audit Management - Biotech/Pharma Experience Require

Lead the end-to-end supplier management lifecycle and audit program, including process ownership, continuous improvement, and audit scheduling (supplier, clinical investigator, and internal audits); oversee Quality Agreement and Risk Management processes.Do you have the right skills and experience for this role Read on to find out, and make your application.Establish, maintain, and continuously improve QMS procedures, workflows, metrics, and practices to strengthen compliance and operational effectiveness.Oversee the internal audit program and ensure associated process improvements are established, executed, and monitored for effectiveness.Manage all aspects of documentation and records retention for supplier and audit management, including the routing and approval of documents, archival, and period review.Partner with Manufacturing, Quality Control, Validation, Regulatory Affairs, Supply Chain, Clinical Development, and Clinical Operations to ensure appropriate application of QMS requirements across operations.Lead, support and participate in regulatory authority inspections.Manage external contractors and, where applicable, lead, coach, and develop QMS personnel, including prioritization of work, performance oversight, and support for professional development.Serve as business owner for Quality-owned systems (e.g., Support internal audits, customer audits, and regulatory inspections by ensuring quality systems and associated records are inspection-ready at all times. xevrcycStrengthen the Quality culture by leading cross-functional Quality initiatives.Bachelor's degree in chemistry, biology, microbiology, industrial pharmacy, or other related scientific discipline with a minimum of 10 years' experience in Quality preferredExperience auditing suppliers, CRPs, CMOs, CTLs and clinical sitesPractical knowledge of supplier and audit management across US, EU and ROW regulated environmentsWorking knowledge of electronic quality management systems, learning management systems, data retrieval, and electronic file formats; Experience working within a global Phase I though commercial QMS companyDetail-oriented with strong communication, organizational, and time management skills a mustHighly proficient in Microsoft Office, especially MS ExcelWillingness to travel up to 25%Medical, dental, vision, and life insuranceCompany Equity (New Hire Awards, Annual Awards, ESPP)Company Holidays: 13 days plus summer recharge week in July and winter shutdown in DecemberPaid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability