Associate Director, Quality Assurance Compliance

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

AtGileadour 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 worlds 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.

We prefer a candidate that is site-based (local to Foster City). You will be on site Tuesday Wednesday Thursday. For non-local talent we are open to remote.

As an Associate Director Quality Assurance Compliance at Gilead you will have the following responsibilities:

Inspection Operation and Logistics (Foster City):

• Manages the logistics to support regulatory inspections at GSI Foster City including notification process inspection support team (IST) prep room and inspection rooms and post-inspection activities

• Build inspection readiness tools templates and training materials for perpetual readiness for GSI FC including inspection system training inspection support team (host scribe request champion SMEs Facilities IT etc.)

• Provide logistics support for partner audits including training inspection coordination and prep room support.

• Management of all inspection related documentation including document retention and tracking (pre-inspection notification documents reviewed/retained/requested by investigator/agency)

• Management of post-inspection activities including upload of inspection documents in GVault; coordination and assessment of inspection observation response from key stakeholders maintenance of evidence binder and coordination of the inspection readiness of the evidence binders and/or storyboards

• Management of inspection systems utilized to support inspections including guides tools troubleshooting and training (i.e. MSTeams Sharepoint Zoom)

• Coordinate site inspection logistics with the different cross functional groups including general notification investigator needs conference room set-up (printers boards zoom phones office supplies laptops iPad/cart for virtual tours) and inspection support team assignment and schedule

• Develop and maintenance of Inspection Readiness MSTeams/SharePoint as a centralized resource for inspection readiness support and resources for FC PDM Organization

General and PAI Readiness (Foster City and Global):

• Responsible for the management and maintenance of regulatory inspection procedures and documentation including Regulatory Inspection Policy Site Master File Opening Presentation and other related procedures

• Lead PAI readiness activities by partnering with project teams to evaluate inspection readiness of the team including coordination of a mock inspection as needed

• Lead periodic inspection readiness activities for GSI FC including annual mock inspection inspection logistics drill inspection readiness meeting with different function areas that will support and participate during an inspection (Management Inspection Support Team Security Administrative Assistance Facilities and IT)

• Lead global inspection readiness activities and meetings to share best practices and collaborate on inspection readiness topics and projects; identify and drive improvements

• May support mock PAI inspections as part of audit team

• Oversees the provision of inspection related training

Developing and Implementing Inspection Strategies:

• Design and implement comprehensive inspection plans for all manufacturing sites including raw materials in-process materials and finished products aligned with regulatory requirements.

• Establish standardized inspection procedures and methodologies across global operations.

• Oversee the implementation of advanced inspection technologies to enhance accuracy and efficiency.

Regulatory Compliance:

• Stay abreast of all relevant regulatory requirements related to product quality data integrity and supplier management.

• Ensure compliance with regulatory agencies like FDA EMA and other relevant authorities.

• Assesses proposed corrective or preventive actions in response to audit or inspection findings tracks and reports closure of items and provides management visibility to areas of risk or concern.

• Act as liaison for regulatory inspection for GSI FC PDM inquiries (such as license renewal manufacturers questionnaire drug manufacturing license etc.)

Quality Improvement Initiatives:

• Lead or support continuous improvement efforts within Inspection Management to enhance quality standards and operational efficiency.

• Analyze quality data to identify inspection trends and opportunities for improvement.

Digital Data & AIEnabled Inspection Readiness:

• Leverage data analytics digital tools and emerging AIenabled capabilities to enhance inspection readiness inspection intelligence and risk identification across sites.

• Partner with Quality IT and Digital teams to evaluate pilot and operationalize AIsupported tools (e.g. document triage trend detection inspection metrics dashboards) in a GxPcompliant and inspectiondefensible manner.

• Ensure AIenabled solutions used in inspection preparation and execution are appropriately governed validated where required and aligned with data integrity cybersecurity and privacy expectations.

• Use inspection data audit outcomes and quality signals to support riskbased decisionmaking and continuous improvement initiatives.

Other:

• May support Audit Programs including internal audits site audits affiliate and 3PL audits as needed

• Position may include travel (up to 50%)

• Other responsibilities as required

Requirements:

• BS/BA degree in Biology Sciences or related discipline and a minimum of 10 years of related experience; OR

• MS/MA degree in Biology Sciences or related discipline and a minimum of 8 years of related experience; OR

• PhD in related discipline and a minimum of 5 years of related experience

Knowledge & Behaviors:

• Experience in the biotech or pharmaceutical industry is required.

• Experience in managing Health Authorities during inspection; previous Regulatory Health Agency investigator experience preferred

• Experience in managing Customer/Business Partners during

• ledge and practical application of domestic and global regulations including 21 CFR Parts20; EudraLex Volume 4 and applicable annexes; EU Good Distribution Practices for Medicinal Products QMSR/ISO13485 and Health Canada GMP/GDP guidance; as well as ICH ISO and USP / EP compendial standards

• Detailed knowledge of the manufacturing and testing processes associated with APIs Oral Solid Drug Product Liquid Formulations Biologics Aseptic Fill / Finish Primary and Secondary Packaging Medical Device and Warehousing / Distribution

• Applies most current market regulations functional trends quality standards and techniques to deliver high quality work

• Well recognized as a knowledgeable and credible resource for QA compliance in other departments

• In-depth knowledge of audit process and risk-based principles

• Excellent knowledge of computer systems; i.e. Microsoft Word Excel Powerpoint MSTeams and Veeva Vault

• Working knowledge of AI machine learning and advanced analytics concepts as applied to Quality Compliance and Inspection Management.

• Experience using or supporting digital quality systems and analytics platforms (e.g. dashboards document management systems inspection intelligence tools) to improve inspection outcomes and operational efficiency.

• Understanding of AI governance principles including data integrity validation expectations human oversight and appropriate use in regulated GxP environments.

• Ability to translate complex data and AIenabled insights into clear actionable inspectionready narratives for Health Authorities and senior leadership.

• Good leadership and organizational skills ability to work independently under minimal direction

• Strategic visionary and able to design well-written well-organized and professional documents and presentations including outputs and actions

• Effective communication skills within a matrix management environment (verbal written and presentation)

• Team player with excellent intrapersonal skills and with the ability to work in a matrix organization

People Leader Accountabilities:

• Create Inclusion -knowingthe 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 employeesare receivingthe feedback and insight needed to growdevelopand realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals purpose and organizationalobjectives 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:

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:

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 disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view theKnow 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.