Senior Director of External Quality Operations- Packaging

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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. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Working in QA at Gilead:

Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are committed to the successful delivery of safe life-changing therapies.

Job Summary:

Gilead Sciences is currently seeking a Senior Director level position to be the leader of Packaging Quality Assurance Team in the Pharmaceutical Development and Manufacturing (PDM) organization. The Packaging Quality Assurance Team provides quality oversight of GMP activities at Gilead’s contract organization global network supporting the packaging of clinical and commercial for clinical trials and commercial distribution respectively. The leader of Packaging Quality Assurance Team is a key strategic member of Quality Assurance management team in continually assessing quality systems, providing guidance and direction for implementation of effective and efficient quality processes. The candidate must have demonstrated leadership skills and with extensive working knowledge of clinical and commercial packaging operations, familiar with relevant GMP and regulatory requirements for US, EU, and other countries where Gilead’s clinical trials are conducted, and commercial products are distributed. The candidate must have prior leadership experience at contract manufacturing organizations or have direct experience overseeing contract manufacturing organizations. The successful candidate must be extremely familiar with applicable regulations and requirements with outsourced operations and clarity of the role and responsibilities between marketing authorization holder and contract manufacturing organization. The candidate must possess strong communication, influencing and negotiation skills, be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact to the business and be able to partner with leaders in in Portfolio Strategy team, Manufacturing, Packaging, Supply Chain, Regulatory CMC, and the wider PDM Quality organization to achieve business objectives. The successful candidate must have proven track records in leading packaging operations in a biotech or pharmaceutical development environment and strong knowledge of cGMP quality systems and have extensive experience in managing audits, inspections, and health authority interactions.

Job Functions:

• Execute an integrated and sustainable external quality strategy and company content priorities for Gilead’s clinical and commercial products and contract organizations based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs.

• Develop proce