Director, Global Supplier and External Manufacturing Quality

ppThis senior leadership role is responsible for defining and executing the global quality strategy all Quality activities related to suppliers, contract manufacturers (CMOs), external partners, and outsourced operations across the full product lifecycle. The position ensures compliance with GMP, GDP, and applicable regulatory requirements while driving continuous improvement and operational excellence throughout the external supply network. /p h3Key Responsibilities /h3 h3Strategic Leadership /h3 ul liDevelop and implement a global quality strategy for external manufacturing and suppliers aligned with corporate objectives and regulatory standards. /li liEstablish governance for supplier qualification, performance monitoring, and lifecycle management. /li /ul h3Supplier External Manufacturing Oversight /h3 ul liOwn the global supplier and CMO Quality Management System (QMS). /li liApprove and maintain the global supplier/CMO portfolio, including: /li liQualification and onboarding /li liQuality agreements /li liPerformance monitoring and scorecards /li liPeriodic business reviews /li /ul h3Compliance Risk Management /h3 ul liEnsure timely release of externally manufactured products. /li liOversee product quality reviews (PQR/APR) and device post‑market surveillance. /li liEnsure adherence to GMP, GDP, ISO standards, and global regulatory requirements (FDA, EMA, ICH, PMDA). /li liOversee global audit programs and regulatory inspection readiness for external sites. /li /ul h3Issue Resolution Continuous Improvement /h3 ul liDrive investigations, CAPAs, and root cause analysis for deviations and complaints. /li liImplement supplier improvement initiatives and risk mitigation strategies. /li liLead escalation and crisis management for supplier or CMO quality events /li /ul h3Cross-Functional Collaboration /h3 ul liPartner with Procurement, Supply Chain, Regulatory, Development to ensure seamless operations and compliance. /li liLiase with Plant Supplier Qualification teams to identify synergies and streamline processes /li liSupport the internal plants during regulatory inspections and internal/external audits. /li liProvide Quality leadership for strategic programs such as: /li liNew product introductions /li liNetwork expansions /li liDigital quality initiatives /li liBuild and lead a global team of quality professionals, fostering a culture of accountability and excellence. /li /ul h3Qualifications /h3 ul libEducation: /b Degree in Life Sciences, Pharmacy, Chemistry, or Engineering; advanced degree (MBA or comparable) preferred. /li libExperience: /b /li li12+ years in pharmaceutical/CHC quality roles, with at least 2 years in global leadership. /li liProven experience in external manufacturing and supplier quality management. /li liProven experience in digital tools and eQMS system for the management of suppliers /li libSkills: /b /li liDeep knowledge of GMP, QMS, and regulatory frameworks. /li liStrong leadership, negotiation, and stakeholder management skills. /li libOther: /b /li liFluent in English; any additional languages a plus. /li liWillingness to travel internationally (30–50%). /li /ul /p #J-18808-Ljbffr