Manager, Quality Assurance Distribution

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.

The QA Manager (US market) a member of the Global Product Distribution & Affiliates (GPD&A) group supports distribution of Gilead products (including prescription samples) within the US market. This role acts as Designated Representative (DR) for Asegua Therapeutics LLCs (Asegua) a wholly owned subsidiary of Gilead Sciences Inc and works closely with their manager as well as the Director QA (US) and with internal & external stakeholders to ensure quality requirements are met and compliance to Good Distribution Practise (GDP) is adhered to for Gilead products throughout the US distribution network to patients.

Key Responsibilities:

• Act as Designated Representative (DR) for Asegua responsible for ensuring compliance with National Association or Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements as well as all relevant regulations pertaining to current best practice

• Responsible for maintaining the Californian Board of Pharmacy Wholesale Drug Permit (license) by ensuring all licensee requirements are met

• Manage medical samples process for Gilead products in the US market and ensure compliance with the Prescription Drug Marketing Act (PDMA)

• Support the engagement program for quality with Gileads US trading partners/customers

• Support operational activities relating to implementation of the Drug Supply Chain Security Act (DSCSA) requirements as required

• Act as Deputy Designated Representative (dDR) for Gilead Sciences Inc. supporting the DR to ensure compliance with state pharmacy state and federal laws and regulations pertaining to current best practice

• Support market actions including recall of Gilead/Asegua products distributed in US market

• Support Complaints process for US market and investigations into suspect product as required.

• Generate review and/or approve QMS records such as deviations (internal & external) CAPAs & Change Controls related to QA Operations supporting US market

• Support implementation of existing and new US requirements & guidelines pertaining to product distribution in Gileads processes & procedures

• Collaborate with Global QA teams as well as working cross-functionally with Trade Operations personnel and other relevant colleagues supporting all aspects of US product distribution

• Host/Support NAPB audits of Asegua as well as supporting external FDA audits and internal audit programs as required

• Generate & maintain Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met

• Deliver training to colleagues in processes & procedures relevant to GDP compliance as it relates to activities covering US market

• Participate in gap analyses and risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards.

• Participate in local and corporate projects and process improvement initiatives as required.

Knowledge Experience & Behaviors:

• 6 years of relevant experience in the pharmaceutical industry and a BS or BA (a pharmacy degree or equivalent an advantage) or 4 years of relevant experience and a MS or MA.

• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.

• Experience in US market to include supporting FDA inspections.

• Demonstrates proficiency in Good Distribution Practices (GDP) and Drug Supply Chain Security Act (DSCSA) and and Prescription Drug Marketing Act (PDMA) requirements.

• Capable of assessing and communicating the impact of relevant requirements to the business and ability to engage with multiple stakeholders to achieve shared objectives.

• Excellent organization and prioritization skills and ability to work on specified projects with tight timelines is required.

• Demonstrates excellent attention to detail and ability to consistently meet high standards required in Compliance.

• Demonstrates excellent verbal written and interpersonal communication skills.

Gilead Core Values:

• Integrity (always doing the right thing)

• Teamwork (collaborating in good faith)

• Excellence (working at a high level of commitment and capability)

• Accountability (taking personal responsibility)

• Inclusion (encouraging diversity)

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.

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.