Director, Analytical Quality Assurance

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

Gilead Sciences Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases including HIV viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide with headquarters in Foster City California.

Key Responsibilities:

Lead analytical quality oversight for external QC testing laboratories stability programs analytical methods and related GMP analytical operations ensuring activities investigations documentation and quality decisions are scientifically sound risk-based and compliant with applicable regulatory requirements.

Provide quality governance for contract partners and testing laboratories partner cross-functionally with Manufacturing and external partners to support product lifecycle and regulatory priorities and lead the Analytical Quality Assurance team while fostering accountability collaboration and a strong quality culture.

Job Responsibilities:

• Provide quality oversight for contract QC testing laboratory activities stability programs analytical method validation and transfers.

• Review and approve analytical quality documents including SOPs specifications methods change controls protocols reports investigations deviations CAPAs and quality assessments.

• Ensure analytical testing activities comply with applicable quality objectives cGMP GLP ICH FDA EMA and other regulatory requirements.

• Oversee investigations related to OOS OOT atypical results deviations and laboratory incidents ensuring timely scientifically sound resolution and appropriate CAPA recommendations.

• Provide quality oversight for contract partners and contract testing laboratories including qualification performance monitoring audits quality agreements and resolution of documentation or compliance issues.

• Maintain and continuously improve systems and processes for CAPA change control risk management compliance and analytical quality operations.

• Manage audits and inspections related to analytical laboratories and testing activities including regulatory inspections customer audits internal audits and cGMP compliance audits.

• Review and audit analytical data and CMC sections of NDA and global regulatory filings as applicable.

• Manage direct reports responsible for Analytical Quality Assurance.

Knowledge Experience and Skills:

• Demonstrated ability to evaluate analytical data investigations trends and product quality risks to make sound risk-based quality decisions.

• Experience overseeing contract testing laboratories and external partners including performance monitoring issue resolution and quality governance.

• Excellent communication collaboration organization and influencing skills with the ability to effectively engage senior leadership and cross-functional stakeholders.

• Strong critical thinking problem-solving and decision-making skills with the ability to operate independently in complex and ambiguous environments.

• Proven ability to lead coach and develop high-performing teams while fostering a culture of accountability quality and continuous improvement.

Qualifications:

• Experience in pharmaceutical quality analytical sciences Quality Control Quality Assurance or a related GMP-regulated environment with progressive leadership responsibilities. Bachelors degree MS or PhD in chemistry microbiology or related scientific field is preferred:

  • 12 years of relevant experience and a BS or BA

  • 10 years of relevant experience and a MS

  • 8 years of relevant experience and a PhD

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: $210375.00 - $272250.00. 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:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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.

Please apply via the Internal Career Opportunities portal in Workday.