Senior Director Global Quality Operations (a)

pulliInternational biotech company /liliInterim management for 6-12 months /li /ulh3About Our Client /h3pOur client, an international biotech company in Zug area, is looking for a Senior Director Global Quality Operations (a) ad interim (6-12 months). Therefore, bonly candidates that are /b bavailable latest in August /b will be considered. /ph3Job Description /h3pAs Senior Director Global Quality Operations (a) ad interim, you will lead the global Quality Operations across clinical and commercial products, overseeing CMOs and external partners to ensure compliant manufacturing, supply continuity, and regulatory compliance from intermediates through to finished products. Your tasks involve the following: /pulliProviding strategic and operational Quality leadership to ensure timely product release, reliable supply, compliant distribution, and GxP oversight of medicinal products. /liliServing as the international Quality GxP Lead, defining Quality strategy and supporting global business growth and expansion. /liliDeveloping and leading the international Quality organization, aligning affiliate Quality structures and global GMP/GDP Quality Management Systems. /liliEnsuring implementation, maintenance, and continuous improvement of the Quality Management System, including risk management, issue escalation, and inspection readiness. /liliMaintaining end-to-end GMP/GDP oversight across drug substance, intermediates, and drug product manufacturing, release, storage, distribution, and batch traceability. /liliOverseeing qualification, auditing, and performance management of CMOs and Contract Service Providers, including Quality Agreements. /liliEnsuring compliant product handling and distribution, investigating deviations, and managing regulatory notifications where required. /liliLeading batch certification and release, ensuring complete documentation review and release of compliant product only. /liliRepresenting Quality during inspections and audits, leading self-inspections, and driving Quality Management Reviews. /liliCollaborating cross-functionally with Regulatory Affairs, Supply Chain, and other stakeholders to support product lifecycle management and business objectives. /li /ulh3The Successful Applicant /h3ulliDegree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline; advanced qualification preferred. /liliIn-depth knowledge of global pharmaceutical regulations, including FDA (21 CFR Parts 11, 210 and 211), EU GMP (EudraLex Volume 4, including Annexes 1, 13 and 16), GDP requirements, and the Swiss Medicinal Products Licensing Ordinance (SR 812.212.1). /liliExtensive Quality Assurance experience within the pharmaceutical or biotechnology industry, supporting both clinical and commercial products. /liliProven experience with batch disposition, Qualified Person certification, EU importation, health authority inspections, and inspection readiness. /liliStrong expertise in Quality Management Systems, including deviations, non-conformances, root cause analysis, CAPAs, quality risk management, and continuous improvement. /liliDemonstrated experience ensuring GMP/GDP compliance across international manufacturing, distribution, import/export activities, and end-to-end pharmaceutical supply chains. /liliProven experience overseeing CMOs, Contract Service Providers, supplier qualification, Quality Agreements, and audits. /liliDemonstrated leadership experience building and leading international Quality organizations, with the ability to collaborate effectively across Regulatory Affairs, Supply Chain, Manufacturing, and Technical Operations. /liliStrategic, hands‑on leadership style with excellent stakeholder management and communication skills in a global matrix environment. /liliFluent English; additional European languages are an advantage. /li /ulh3What's on Offer /h3ulliHigh-impact global leadership role with broad strategic influence. /liliOpportunity to build and strengthen an international Quality organization. /liliCollaborative, agile biotech environment with meaningful patient impact. /li /ul /p #J-18808-Ljbffr