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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

Senior Director,** **External Q** **uality Testing** **Operations

This role can be based in Foster City, CA or Parsippany, NJ

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Working in PDM Global Quality at Gilead:

Pharmaceutical Development & Manufacturing (PDM) Global Quality delivers on Gilead’s commitment to bring life-changing therapies to patients through robust Quality 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 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 ofcontracttestingorganization global network and ensuremanufactured products aresafe and effective.

+ Thesuccessfulcandidate must have demonstrated leadership skills and extensive working knowledge ofmanagingoutsourcedtesting operations, fromsite 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 capabilityat the contract testing laboratories.

+ Thesuccessfulcandidate must have prior leadership experience at contracttestingorganizations or have extensive experience overseeing contracttesting organizations.

+ Thesuccessfulcandidate must be extremely familiar with applicable regulations and requirements with outsourced operations and clarity of the role and responsibilities between market authorizationholderand contracttestingorganizations.

+ Thesuccessfulcandidate 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 QualityControlfunctions in a biotech or pharmaceutical development environment and strong knowledge of cGMPlaboratoryquality system and have extensive experience in managing audits,inspectionsand health authority interactions.

Job Functions:

+ Execute an integrated and sustainable external qualitycontrol testingstrategyfor Gilead’s clinical andcommercial products based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs.

+ Develop processes to communicatelearnings anddrive any relatedquality control testingactivities for Gilead’s clinical and commercial products in support of arobustcompliantmethodlifecyclemanagement program.

+ Develop a process for exchange of lessons learned across multiple company representatives andidentifyopportunities for Gilead’s process improvements.

+ Collaborate withTechnical andQuality leadership toidentifysolutions andprocesses andalign with key partners on implementation of new requirements.

+ Implement continuous improvement initiatives to drivequalitycontrol testingprograms and ensure maximum productivity.Ensuringsystems 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,andmonitorqualitycontrol testingprograms, policies,and procedures to ensure compliance withGxPstandards, corporate policies, FDA, EMA,and other regulatory body regulations and guidelines.

+ Set and drive compliance to department, site and global KPIs.

+ Evaluate all currentqualitycontrol testingsystems and processes and recommend and implementappropriate enhancementsandtrainingto ensure the achievement of Gilead long-termobjectives.

+ Professionalorganization engagement and representation; benchmarking in industry networks.

+ Provide guidance to the business teams on technical regulatory requirements and lead andassistwhere needed.

+ Participatein different internal business and technical forumsas Quality’s voice forcontract testing organizations’oversight.

+ Conduct regular review and assessment ofregulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion.

+ Think and act globally toanticipatepotential problems and risks related to regulatory compliance expectations.

+ Approximately 20%travelis expected.

Knowledge, Experience and Skills:

+ Expert inquality requirementspertaining tooutsourcedtestingoperationsandcontract testinglaboratorydesign,operationsand maintenance, with strong emphasis on data integrity.

+ In-depth understanding and application of GMP principles, concepts, best practices,and standards in the USand internationally.

+ Demonstrated ability todevelop and improve complex concepts, techniques,andstandards and new applications based on quality principles and theories.

+ In-depthknowledgeofGlobal requirements/standards for product registration and life-cycle management of product qualitycontrol testing.

+ Demonstrated ability to developsolutions 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.

+ Abilityto interactwith regulatory agenciesisneeded andpossessesthe ability torepresentGilead in public forums.

+ Demonstratedexperience and ability to manageteamof highly technicalstaff.

+ Expert inmanagingresources to address competingprojectsandtimelines.

Basic Qualifications:

+ 12 - 15 years of relevant experience and abachelor’s degree in scienceor related fields;or8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.

+ Priorleadershipexperiencein a complex organizationa must.

+ Expert knowledge intechnical and regulatory requirementspertaining tolaboratory controls and outsourcedtestingoperationsisa must.

+ Biopharmaceutical or Pharmaceutical experiencea must.

+ Prior experienceleading contracttestingoperations oroverseeing contracttestingoperationsis a must.

+ Experience withtesting operations indifferent pharmaceutical modalities, e.g., parenteral, biologics,oral solid dosage,and medical devicepreferred.

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*.

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.