Director of Quality and Compliance (US)

Director, Quality & ComplianceLocation: United StatesA leading global CDMO is seeking a Director of Quality & Compliance to provide strategic oversight across quality systems, regulatory compliance, and inspection readiness within a complex biologics manufacturing environment.This is a senior leadership role, responsible for driving a best-in-class quality culture while ensuring full alignment with global regulatory standards and customer expectations.The RoleAs a key member of the Quality Leadership Team, you will:Provide end-to-end oversight of Quality Systems, Compliance, and Data IntegrityLead functions including:Quality SystemsAudits & InspectionsSupplier QualityValidation QAData IntegrityAct as the primary quality representative for regulatory and customer inspectionsDrive continuous improvement initiatives to enhance compliance, efficiency, and quality performancePartner closely with Operations, MS&T, and senior leadership to embed GMP excellence and quality cultureOversee quality strategy for high-value, complex customer programsEstablish and monitor site quality metrics, KPIs, and customer satisfaction indicatorsLead proactive risk management and compliance strategies aligned with evolving global regulationsRepresent Quality on governance committees and advise leadership on regulatory risks and opportunitiesKey ResponsibilitiesEnsure full compliance with global cGMP standards and regulatory requirementsLead and manage cross-functional quality teams, driving performance and accountabilityOwn inspection readiness and serve as lead during regulatory authority and client auditsDevelop and implement long-term quality and compliance strategiesDrive right-first-time culture and proactive quality improvementsCollaborate with customers to anticipate and meet future regulatory expectationsLead talent development, succession planning, and team capability buildingInfluence senior stakeholders across a matrixed, global organisationCandidate ProfileBachelor’s degree in Life Sciences, Engineering, or related field (advanced degree preferred)10+ years’ experience in GMP-regulated pharmaceutical/biologics environmentsStrong background in Quality Systems & Compliance leadershipProven experience leading regulatory inspections (FDA, EMA, etc.)Deep understanding of:CDMO environmentsQuality Assurance & Regulatory frameworksData Integrity & ValidationDemonstrated ability to lead high-performing teams and drive organisational changeStrong stakeholder management skills, with experience influencing at senior/executive levelExperience in complex, multi-site or global operations highly desirableWhy Apply?Join a high-growth, global CDMO at the forefront of biologics manufacturingPlay a critical leadership role shaping quality strategy and compliance standardsHigh visibility position with direct impact on business performance and customer successCompetitive compensation package including bonus and comprehensive benefits