Director, Quality Compliance and Audits

仕事内容

The Director, Quality Compliance and Audits (QCA) reports to the Executive Director, Quality Compliance & Audits and provides strategic leadership and governance for Gilead’s global GMP and GDP audit program. This role leads and develops a team of auditors and ensures consistent, high‑quality audit execution across Gilead’s global manufacturing and supply network, including internal manufacturing facilities, external contract manufacturers, laboratories, suppliers, distributors, and other third‑party partners.

The Director is accountable for oversight of the end‑to‑end audit lifecycle, including development and execution of the annual audit plan, and ensures audits are performed as systematic, independent, and objective assessments of compliance with global regulatory requirements, internal quality policies, and industry standards. The role partners closely with cross‑functional stakeholders to ensure compliance risks and systemic issues identified through audits are appropriately documented, escalated, trended, and resolved, while driving consistency, continuous improvement, and sustained quality oversight across Gilead’s global supply chain.

Essential Duties and Responsibilities:

• Manage and develop an auditing team, including work planning and prioritization, performance monitoring, coaching, feedback, and formal performance reviews.

• Foster a culture of quality, accountability, and continuous improvement within the audit program.

• Serve as a member of the Quality Compliance & Audits Leadership Team helping to define strategy, deliver on business goals, and collaborate with other cross-functional teams across Gilead and Kite

• Establish and execute a risk‑based annual audit plan.

• Monitor regulatory requirements, enforcement trends, and inspection intelligence; assess potential impacts to Gilead’s manufacturing and supply network; and proactively incorporate these insights into risk‑based audit planning and coverage.

• Promote awareness of current regulatory expectations across clinical and commercial manufacturing platforms and incorporate identified trends into audit program strategy and focus.

• 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, spanning multiple modalities including small molecules, biologics, and medical devices/combination products.

• Drive consistency and quality in audit observation writing, finding classification, risk assessment, and documentation.

• Identify, assess, and appropriately escalate compliance risks and systemic issues to management to support timely evaluation and resolution.

• Evaluate, govern, and implement the appropriate use of AI enabled tools and digital solutions to enhance audit effectiveness, consistency, and efficiency across the global audit program.

• Collaborate with cross‑functional stakeholders to identify compliance gaps, emerging risks, and opportunities for proactive compliance or continuous improvement initiatives.

• Provide expert guidance on the interpretation and application of new and existing regulatory requirements and advise audit team, management, and functional areas on complex compliance matters.

• Support the evaluation, development, and implementation of processes, procedures, tools, templates, and systems necessary to maintain a robust global audit program that drives continuous improvement and proactive compliance across Gilead's global supply chain.

• Oversee systems and data used to manage the global audit program, including ensuring accuracy and integrity of information within Gilead's internal systems.

Supervisory Responsibilities:

• Supervise direct reports.

• Supervision of contingent workforce and consultants

• Develops talent, including development planning, for both direct reports and indirect reports, through mentoring.

Experience/Knowledge/Skills:

• Demonstrated experience in the biotechnology or pharmaceutical industry is required.

• Proven GMP/GDP auditor with experience conducting audits and leading, managing, and developing a team of auditors.

• Experience engaging with Health Authorities during regulatory inspections is desirable.

• Prior experience within a regulatory authority is desirable.

• Expert knowledge of GMP and GDP regulations, global regulatory expectations, and inspection practices.

• Excellent verbal, written, and interpersonal communication skills, with the ability to communicate effectively across technical, operational, and executive audiences.

• Highly experienced in actively listening to and integrating diverse perspectives to develop well‑reasoned solutions and effectively advocate for a position.

• Demonstrated accountability for actions, a strong results orientation, and the ability to learn from experience and continuous feedback.

• Demonstrates sound judgment and logical, analytical thinking in collecting, evaluating, and synthesizing information to support independent and timely decision‑making.

• Effectively communicates, influences, and escalates issues and decisions, as appropriate, to support risk‑based and timely resolution.

Education/Experience:

• BS/BA degree in Biology, Sciences, or related discipline and a minimum of 12 years or related experience; or

• MS/MA degree in Biology, Sciences, or related discipline and a minimum of 10 years of related experience; or

• Equivalent combination of education and experience.

Travel:

• 30% travel required