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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

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:

+ Knowledgeable in quality requirements pertaining to manufacturing, testing, packaging, labeling, facility, utility, equipment and process validation, cleanroom classification and qualification, new product introduction, multi-product facility control, contamination control strategy, technology transfer, contract operations, product release, disposition, and distribution.

+ 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 principles and theories.

+ Knowledgeable in Global requirement/standards for product registration and life cycle management of product quality.

+ Demonstrated ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.

+ Excellent verbal, written, and interpersonal communication skills.

+ Expert in prioritizing workload to address competing projects and timelines.

Basic Qualifications:

+ 12+ years of relevant experience and a bachelor’s degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.

+ Prior experience leading, developing and managing people.

+ Knowledge in technical and regulatory requirements pertaining to manufacturing, testing,product lifecycle management, and outsourced operations a must.

+ Biopharmaceutical or Pharmaceutical experience a must.

+ Prior experience leading contract manufacturing/testing operations or overseeing contract manufacturing operations a must.

+ Significant experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred.

+ Prior people management experience required.

+ Broad experience across several areas like CMO QA, Validation, Drug development experience, packaging/labeling and understanding of Parenteral, OSD, and Biologics.

People Leader Accountabilities:

•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the

way they manage their teams.

•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current

performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and

realize their purpose.

•Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding

them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

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

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.