Director, Quality Site Lead

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

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life‑threatening illnesses worldwide. We are seeking a Director, Quality Site Lead located in Foster City, CA.

Job Functions

• Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned Strategic Gilead CXO partners / sites.
• Assure CXOs meet Gilead’s quality, regulatory and compliance standards, to ensure a sustainable delivery of quality products to patients.
• Key member of Business Review Meetings with CXO as Quality’s voice for the contract organizations’ oversight. Maybe member or backup member of Joint Steering Committee.
• Ensure contract manufacturers are compliant and ready for regulatory inspections and monitor progress during inspection. Support onsite inspections to ensure compliance and readiness, as needed.
• Accountable for multiple external QA functions, including quality events, validation, and release / disposition.
• Partner with internal stakeholders such as Global External Manufacturing, Global Supply Chain, Pharmaceutical Development, and Reg CMC, to identify solutions and processes and align with key partners on implementation of new requirements; proactively address.
• Lead escalations for critical quality issues.
• Evaluate current quality systems and processes and recommend and implement appropriate enhancements and trainings to ensure the achievement of Gilead long‑term objectives.
• Monitor CXO site trends, holding CXO accountable to established performance criteria and QAG requirements.
• Travel to CXO site(s) to provide Quality oversight of critical manufacturing activities, as required.
• Ensure GMP documentation is accurate and compliant with internal and external standards and requirements.
• Provide guidance to the business teams on regulatory requirements and assist where needed.
• Establish and foster meaningful Quality to Quality relationships between Gilead and CXOs.
• Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion.
• Partner with Manufacturing, Development, Global Supply Chain, Global QC and Outsourcing to deliver on the production plan.
• Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.
• May back up Pillar Lead, as needed.
• Champion Quality Risk Management, identifying key risks impacting CXO performance.
• Ensure PAI / PLI Readiness for assigned CXO sites.
• Up to 20% travel based on strategic plan.
• Manages a team of Quality Professionals.

Knowledge, Experience And Skills

Basic Qualifications

People Leader Accountabilities

Salary & Benefits

The salary range for this position is : $210,375.00 – $272,250.00. 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

For Additional Benefits Information, visit https : / / www.gilead.com / careers / compensation-benefits-and-wellbeing

Equal Employment Opportunity

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, gender identity and expression, veteran status, or other non‑job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. Applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

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