Sr Director, External Quality Testing Operations

Senior Director, External Quality Testing Operations

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.

Gilead Sciences PDM External Quality is currently seeking a leader at the Senior Director level to lead a team of over 50 Quality Professionals to provide quality oversight of GMP activities at Gilead's contract testing organization global network supporting the release, stability and characterization testing to enable clinical and commercial product submission, release and distribution.

Being a member of the External Quality Leadership team, the successful candidate is expected to work collaboratively with internal and external networks to continually improve Gilead's oversight model of contract testing organization global network and ensure manufactured products are safe and effective.

The successful candidate must have demonstrated leadership skills and extensive working knowledge of managing outsourced testing operations, from site selection, qualification, scheduling, sample shipment, monitor adherence to schedule performance, as well as providing quality oversight for laboratory investigations, and ongoing monitoring of method performance, capacity and technical capability at the contract testing laboratories.

The successful candidate must have prior leadership experience at contract testing organizations or have extensive experience overseeing contract testing organizations. The successful candidate must be extremely familiar with applicable regulations and requirements with outsourced operations and clarity of the role and responsibilities between market authorization holder and contract testing organizations.

The successful 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 different PDM functions including Product and Portfolio Strategy, Global Manufacturing, Supply Chain, Regulatory CMC, and the wider Quality organization to achieve business objectives.

The successful candidate must have proven track records in leading different Quality Control functions in a biotech or pharmaceutical development environment and strong knowledge of cGMP laboratory quality system and have extensive experience in managing audits, inspections and health authority interactions.

Job Functions :

• Execute an integrated and sustainable external quality control testing strategy for Gilead's clinical and commercial products based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs.
• Develop processes to communicate learnings and drive any related quality control testing activities for Gilead's clinical and commercial products in support of a robust compliant method lifecycle management program.
• Develop a process for exchange of 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 quality control testing programs and ensure maximum productivity. Ensuring systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
• Develop, implement, and monitor quality control testing programs, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines.
• Set and drive compliance to department, site and global KPIs.
• Evaluate all current quality control testing systems and processes and recommend and implement appropriate enhancements and training to ensure the achievement of Gilead long-term objectives.
• Professional organization engagement and representation; benchmarking in industry networks.
• Provide guidance to the business teams on technical regulatory requirements and lead and assist where needed.
• Participate in different internal business and technical forums as Quality's voice for contract testing organizations' oversight.
• Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion.
• Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.
• Approximately 20% travel is expected.

Knowledge, Experience and Skills :

Basic Qualifications :

The salary range for this position is : Bay Area : $243,100.00 - $314,600.00. Other US Locations : $221,000.00 - $286,000.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

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