Job DescriptionThe 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
The salary range for this position is: $165,495.00 - $214,170.00. 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.
