Senior Director Global Quality Operations (a)

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.