Senior Director Global Quality Operations (a)

• International biotech company
• Interim management for 6-12 months

About Our Client

Our client, an international biotech company in Zug area, is looking for a Senior Director Global Quality Operations (a) ad interim (6-12 months). Therefore, only candidates that are available latest in August will be considered.

Job Description

As 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:

• Providing strategic and operational Quality leadership to ensure timely product release, reliable supply, compliant distribution, and GxP oversight of medicinal products.
• Serving as the international Quality GxP Lead, defining Quality strategy and supporting global business growth and expansion.
• Developing and leading the international Quality organization, aligning affiliate Quality structures and global GMP/GDP Quality Management Systems.
• Ensuring implementation, maintenance, and continuous improvement of the Quality Management System, including risk management, issue escalation, and inspection readiness.
• Maintaining end-to-end GMP/GDP oversight across drug substance, intermediates, and drug product manufacturing, release, storage, distribution, and batch traceability.
• Overseeing qualification, auditing, and performance management of CMOs and Contract Service Providers, including Quality Agreements.
• Ensuring compliant product handling and distribution, investigating deviations, and managing regulatory notifications where required.
• Leading batch certification and release, ensuring complete documentation review and release of compliant product only.
• Representing Quality during inspections and audits, leading self-inspections, and driving Quality Management Reviews.
• Collaborating cross-functionally with Regulatory Affairs, Supply Chain, and other stakeholders to support product lifecycle management and business objectives.

The Successful Applicant

• Degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related scientific discipline; advanced qualification preferred.
• In-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).
• Extensive Quality Assurance experience within the pharmaceutical or biotechnology industry, supporting both clinical and commercial products.
• Proven experience with batch disposition, Qualified Person certification, EU importation, health authority inspections, and inspection readiness.
• Strong expertise in Quality Management Systems, including deviations, non-conformances, root cause analysis, CAPAs, quality risk management, and continuous improvement.
• Demonstrated experience ensuring GMP/GDP compliance across international manufacturing, distribution, import/export activities, and end-to-end pharmaceutical supply chains.
• Proven experience overseeing CMOs, Contract Service Providers, supplier qualification, Quality Agreements, and audits.
• Demonstrated leadership experience building and leading international Quality organizations, with the ability to collaborate effectively across Regulatory Affairs, Supply Chain, Manufacturing, and Technical Operations.
• Strategic, hands-on leadership style with excellent stakeholder management and communication skills in a global matrix environment.
• Fluent English; additional European languages are an advantage.

What's on Offer

• High-impact global leadership role with broad strategic influence.
• Opportunity to build and strengthen an international Quality organization.
• Collaborative, agile biotech environment with meaningful patient impact.