Senior Director, Global Supplier Quality

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID‑19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

Join Gilead and help create possible, together.

• Lead a team of 10–15 Quality Professionals to define, lead and manage the Global Supplier Quality program by providing quality oversight of GMP material and commodity suppliers.
• Collaborate with internal and external networks to continually improve Gilead’s Global Supplier Quality program, from selection, onboarding, qualification, and routine quality and performance oversight of global and local GMP material and commodity suppliers.
• Demonstrate leadership skills and extensive working knowledge of managing GMP material and commodity suppliers’ performance and relationships.
• Manage a matrix organization comprising Supplier Quality members from each of Gilead’s sites.
• Apply technical understanding of different material categories supporting GMP manufacturing of Gilead product modalities.
• Influence Gilead’s external network on selection of GMP material and commodity suppliers in alignment with Gilead’s standards.
• Maintain familiarity with applicable regulations and requirements relating to GMP material and commodity supplier management and the clear delineation of responsibilities between marketing authorization holders and contract manufacturing organizations.
• Communicate, influence and negotiate to evaluate options and trade‑offs and utilize resources to achieve the most positive business impact; partner with leaders in PDM functions (Technical Development, Packaging Development, Engineering, Global Manufacturing, Procurement, Regulatory CMC, and Site Quality) to achieve objectives.
• Possess a proven track record in leading Global Supplier Quality programs in other global biotech or pharmaceutical companies, preferably with established relationships with reputable GMP material and commodity suppliers.

• Execute an integrated and sustainable Global Supplier Quality strategy for Gilead’s clinical and commercial products.
• Develop processes to communicate lessons learned and drive supplier quality improvement initiatives.
• Create a process for exchanging lessons learned across multiple company representatives and identify opportunities for Gilead’s process improvements.
• Collaborate with Technical and Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements.
• Implement continuous improvement initiatives to drive the Global Supplier Quality program and ensure maximum productivity.
• Develop, implement, and monitor Global Supplier Quality program, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory bodies.
• Set and drive compliance to department, site and global KPIs.
• Evaluate current Global Supplier Quality systems and processes and recommend and implement appropriate enhancements and training.
• Engage and represent professional organizations; benchmark in industry networks.
• Provide guidance on technical regulatory requirements and lead assistance where needed.
• Participate in internal business and technical forums as Quality’s voice for GMP material and commodity supplier oversight.
• Conduct regular review and assessment of regulatory intelligence and communicate concerns, trends, gaps, and alerts to Quality management promptly.
• Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.
• Approximately 20% travel is expected.

• Expert in quality requirements pertaining to GMP material and commodity supplier management with strong emphasis on quality and performance management, including risk identification and mitigation.
• In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally.
• Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality…