Associate Director, Quality Assurance

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.

Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through robust QA processes and systems. Our approach is agile, innovative and collaborative across our teams that are committed to the successful delivery of safe life-changing therapies.

Gilead Sciences is currently seeking an Associate Director, External Quality, Clinical Oral Solid Dosage (OSD) to provide quality oversight of GMP activities at assigned Gilead CXOs, supporting the manufacture of small molecule intermediates, drug substances (DS) and drug products (DP) for clinical distribution. This is an independent contributor role who ensures Gilead’s CXOs and clinical programs are proactively led and managed from a quality and compliance perspective and there are no delays to clinical trials. The candidate must have direct experience of overseeing contract manufacturing organizations. The successful candidate must also be extremely knowledgeable of and have a proven track record in clinical development, phase appropriate cGMP application from first-in-human through commercialization, and applicable regulations and requirements.  The candidate must possess strong communication, influencing and negotiation skills and be able to evaluate options, risks, and trade-offs.

Key Responsibilities:

• Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for assigned clinical CXO partners/sites and programs.

• Assure CXOs meet Gilead’s quality, regulatory and compliance standards, to ensure sustainable delivery of clinical products to patients.

• Reviews and approves DS and DP manufacturing batch records, change controls, and deviations to ensure timely disposition of DP intended for human clinical use.

• Integrates acquired clinical assets and serves as Quality Site Lead (QSL) for assigned CMOs and Alliance Partners.

• Leads Quality Agreement implementation and updates with CMOs.

• Key member of Business Review Meetings with CXO as Quality’s voice for the contract organizations’ oversight.

• Ensure contract manufacturers are compliant and ready for regulatory inspections and monitor progress during inspection. Support onsite inspections to ensure compliance and readiness, as needed.

• Partner with internal stakeholders such as Global External Manufacturing, Global Clinical Supply Chain, Pharmaceutical Development, and Reg CMC, to deliver on the production plan, identify solutions and processes, and align with key partners on implementation of new requirements; proactively address.

• Lead escalations and Material Review Boards for critical quality issues.

• Evaluate current quality systems and processes and recommend and implement appropriate enhancements and training to ensure the achievement of Gilead long-term objectives.

• Monitor CXO site trends, holding CXO accountable to established performance criteria and QAG requirements.

• Ensure GMP documentation is accurate and compliant with internal and external standards and requirements.

• Provide guidance to the business teams on regulatory requirements and assist where needed.

• Establish and foster meaningful Quality to Quality relationships between Gilead and CXOs.

• Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion.

• Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.

• Champion Quality Risk Management, identifying key risks impacting CXO performance.

• Travel to CXO site(s) to provide Quality oversight of critical manufacturing activities, as required.

• Up to 20% travel based on strategic plan.

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:

• Knowledgeable in quality requirements pertaining to small molecule OSD manufacturing, testing, packaging, labeling, facility, utility, equipment and process qualification, new product introduction, contract operations, product release, disposition, and distribution.

• In-depth understanding and application of cGMP principles, concepts, best practices, and standards (US and internationally) as applicable to both clinical DS and DP (OSD).

• Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.

• Knowledgeable in Global requirement/standards for product registration.

• Demonstrated ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.

• Excellent verbal, written, and interpersonal communication skills.

• Expert in prioritizing workload to address competing projects and timelines.

• In-depth knowledge of technical and regulatory requirements pertaining to clinical small molecule manufacturing, testing, release, and outsourced operations is a must.

• Biopharmaceutical or Pharmaceutical experience is a must.

• Prior experience leading contract manufacturing/testing operations or overseeing contract manufacturing operations a must. 

• Broad experience across several areas like CMO QA, drug development, packaging/labeling, and deep understanding of clinical OSD (DS and DP) is a must.

• Prior people management experience is a plus.

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: $182,070.00 - $235,620.00. 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.

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.