Director, Analytical Quality Assurance

About this role

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   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.  Bachelor's 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 - 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: $210,375.00 - $272,250.00. 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

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