Senior Director Global Quality Operations (a)

ph3About Our Client /h3 pOur client, an international biotech company in the Zug area, is looking for a Senior Director Global Quality Operations (a) ad interim (6-12 months). Candidates must be available no later than August. /p h3Job Description /h3 pAs Senior Director Global Quality Operations (a) ad interim, you will lead the global Quality Operations during a transition phase across commercial (80%) and clinical products (20%), 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: /p ul liOverseeing qualification, auditing, and performance management of CMOs and Contract Service Providers, including Quality Agreements. /li liMaintaining end-to-end GMP/GDP oversight across drug substance and drug product manufacturing, release, storage, distribution, and batch traceability. /li liEnsuring compliant product handling and distribution, investigating deviations, and managing regulatory notifications where required. /li liLeading batch certification and release, ensuring complete documentation review and release of compliant product only. /li liRepresenting Quality during inspections and audits, leading self-inspections, and driving Quality Management Reviews. /li liProviding strategic and operational Quality leadership to ensure timely product release, reliable supply, compliant distribution, and GxP oversight of medicinal products. /li liEnsuring implementation, maintenance, and continuous improvement of the Quality Management System, including risk management, issue escalation, and inspection readiness. /li liCollaborating cross-functionally with Regulatory Affairs, Supply Chain, and other stakeholders to support product lifecycle management and business objectives. /li /ul h3The Successful Applicant /h3 ul liDegree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline; advanced qualification preferred. /li liIn-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). /li liExtensive Quality Assurance experience supporting clinical and commercial biologics within the pharmaceutical or biotechnology industry; exposure to small molecules on top is an advantage. /li liProven experience with batch disposition, Qualified Person certification, EU importation, health authority inspections, and inspection readiness. /li liStrong expertise in Quality Management Systems, including deviations, non-conformances, root cause analysis, CAPAs, quality risk management, and continuous improvement. /li liDemonstrated experience ensuring GMP/GDP compliance across international manufacturing, distribution, import/export activities, and end-to-end pharmaceutical supply chains. /li liProven experience overseeing CMOs and Contract Service Providers, including supplier qualification, Quality Agreements, and audits. /li liDemonstrated leadership experience building and leading international Quality organizations, with the ability to collaborate effectively across Regulatory Affairs, Supply Chain, Manufacturing, and Technical Operations. /li liEmpathic leadership with excellent stakeholder management and communication skills in a global matrix environment. /li liFluent English; additional European languages e.g. German, are an advantage. /li /ul h3What's on Offer /h3 ul liHigh-impact global leadership role with broad strategic influence. /li liOpportunity to build and strengthen an international Quality organization. /li liCollaborative, agile biotech environment with meaningful patient impact. /li /ul pbContact: /bbr/bQuote job ref: JN- /b /p /p #J-18808-Ljbffr