Associate Director / Auditor, Quality Compliance and Audits
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
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
The Associate Director / Auditor, a member of the Quality Compliance and Audits (QCA) group, is responsible for providing independent quality oversight of Gilead’s extensive global manufacturing and supply network by leading and supporting GMP and GDP audits. This role is accountable for evaluating compliance with applicable global regulatory requirements, internal quality policies, and industry standards across internal manufacturing sites and a broad range of external partners, including contract manufacturers, laboratories, suppliers, distributors, and other third parties, spanning multiple modalities including small molecules, biologics, and medical devices/combination products.
Key Responsibilities:
Independently conduct and support global GMP and GDP audits of Gilead internal manufacturing sites and external partners, including contract manufacturers, laboratories, suppliers, distributors, and other third parties, supporting clinical and commercial oral, parenteral, biologic drug products, and associated combination products and medical devices.
Manage the end‑to‑end audit lifecycle, including audit planning and scheduling, agenda development, audit execution, audit report preparation and issuance, and assessment of responses and adequacy of proposed corrective and preventive actions (CAPAs).
Develop and execute risk‑based audit strategies and agendas that ensure appropriate scope, depth, and focus, incorporating relevant internal and external subject matter experts, as appropriate, to support effective and value‑added audits.
Partner cross‑functionally with Gilead stakeholders to obtain relevant background information, risk assessments, and business context in advance of vendor audits, enhancing audit effectiveness and alignment with quality and organizational objectives.
Contribute to the development, implementation, and continuous improvement of audit procedures, tools, templates, and training materials to promote consistency, quality, and efficiency within the audit program.
Identify compliance gaps, quality risks, and systemic issues, and appropriately escalate significant or complex findings to management to support timely evaluation, prioritization, and resolution.
Ensure consistency, clarity, and quality in audit observation writing, classification, risk assessment, and status tracking, in accordance with internal standards and regulatory expectations.
Perform due diligence assessments and supplier qualification activities to support business expansion, onboarding of new suppliers, and adoption of new technologies and capabilities, as assigned.
Support audit program metrics, continuous improvement initiatives, and established performance goals, while meeting defined timelines and deliverables.
50% travel required
Basic Qualifications:
Bachelor's Degree and Ten Years' Experience
OR
Masters' Degree and Eight Years' Experience
OR
PhD/PharmD and Five Years' Experience
Preferred Qualifications:
Bachelor’s degree (BS or BA) in a relevant scientific or technical discipline with 10+ years of relevant GMP/GDP audit experience in the pharmaceutical or biotechnology industry; or
Master’s degree (MS) in a relevant field with 8+ years of relevant GMP/GDP audit experience; or
An equivalent combination of education, training, and experience.
Demonstrated experience in the biotechnology and/or pharmaceutical industry is required.
Proven GMP/GDP auditor with experience conducting independent audits and contributing to, and where appropriate leading, cross‑functional and team‑based audits.
In‑depth knowledge of GMP/GDP principles and global regulatory requirements, including but not limited to 21 CFR Parts 210 and 211, EU EudraLex Volume 4, and relevant international guidance (e.g., ICH, ISO, PIC/S), as well as applicable compendial standards (e.g., USP, EP).
Comprehensive understanding of manufacturing, testing, and distribution operations across multiple dosage forms and technologies, including APIs, oral solid dosage forms, liquid formulations, biologics, aseptic fill/finish, primary and secondary packaging, and warehousing and distribution.
Strong working knowledge of risk‑based auditing methodologies and the full audit lifecycle, including planning, execution, reporting, and follow‑up.
Demonstrated ability to interpret and apply evolving regulatory expectations, industry trends, and quality standards to deliver high‑quality, compliant audit outcomes.
Excellent written, verbal, and interpersonal communication skills, with the ability to effectively communicate across technical, operational, and executive audiences.
Strong organizational, leadership, and time‑management skills, with the ability to work independently, manage competing priorities, and exercise sound professional judgment.
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
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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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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.