Sr Director, Quality Control

Gilead Sciences • Foster City, CA

4d

About The Position

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 KEY RESPONSIBILITIES: The Senior Director Clinical Analytical Sciences is vital for the success of Clinical Biologics QC, providing strategic leadership and overseeing daily operations. Responsibilities include leading the cGMP QC team that manages the release testing and stability program supporting Gilead’s Clinical biologics drug substances and drug products. The role is accountable for refining clinical QC processes across Gilead’s biologics internal and external manufacturing and testing network, ensuring compliance with global cGMP and Gilead’s Quality Management System. This individual collaborates with cross-functional teams, fosters a culture of continuous improvement, and offers mentorship to the QC team for timely project completion and regulatory compliance. FOCUS AREAS You Will: Oversee the development and implementation of end-to-end Clinical Quality Control strategy for Gilead’s portfolio of biologics products. Have ultimate responsibility for staff development, and contribute to budgeting, cost control, and strategic planning of the Biologics Quality Control department. Provide leadership and guidance to direct reports and project team members to develop strong leaders at Gilead. Lead, motivate, and develop the team, routinely making decisions to ensure project timelines are met. Ensure that Quality Control Systems and practices are developed and implemented internally and externally at contract manufacturing sites and contract laboratories for Clinical biologics. Demonstrate a clear understanding of biological product testing methods and assays for effective troubleshooting, and remediation of atypical results. Act as an escalation point for complex/high impact quality control issues/decisions. Support identification, evaluation, selection, and management CMOs/CTLs, consultants etc. to control quality in support of achieving PDM’s strategic objectives. Establish clear expectations, metrics and KPIs, as appropriate to monitor QC operations and analytical method performance. Be accountable for reviewing data and troubleshooting analytical testing within the Biologics portfolio across internal and external partners. Monitor test method execution in QC laboratories to ensure methods are in a continuous state of control. ·Support validation of analytical methods for new Biologics programs and their transfer to outsourced partners to meet GMP testing needs. Contribute to Regulatory Filings, and responses to Information Requests from Regulatory Agencies. Interface with Regulatory agencies as required representing Gilead to authorities and regulatory inspectorates in matters relating to QC operations and stability studies. Lead or serve as a key project team member on large cross functional projects, often with high visibility to senior management within the organization or with international impact. Provide a long-term view to senior QC Leadership based on personal knowledge of the competitive environment. Support standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Control Systems

Requirements

• Experience over a broad set of Quality Control sub-functions with extensive knowledge of industry best practices and trends.
• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• Must be able to develop solutions to complex problems, which require a high degree of ingenuity and creativity.
• Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.
• Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.
• Demonstrated experience and ability to manage and lead staff, with strong hiring and staff development skills, and the ability to motivate and engage individuals.
• Demonstrated the ability to influence process and outcomes across functions.
• Experience with QC systems such as EDMS and LIMS.
• 14+ years' experience with a BS OR 12+ years’ experience with a MS degree in related fields.
• An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable.
• Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control.
• Stays ahead of shifting trends in industry.
• Prior senior leadership experience required.
• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
• Strong organizational and planning skills.
• Shows excellent verbal and written communication skills and collaborative interpersonal skills.

Nice To Haves

• An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable.

Responsibilities

• Oversee the development and implementation of end-to-end Clinical Quality Control strategy for Gilead’s portfolio of biologics products.
• Have ultimate responsibility for staff development, and contribute to budgeting, cost control, and strategic planning of the Biologics Quality Control department.
• Provide leadership and guidance to direct reports and project team members to develop strong leaders at Gilead.
• Lead, motivate, and develop the team, routinely making decisions to ensure project timelines are met.
• Ensure that Quality Control Systems and practices are developed and implemented internally and externally at contract manufacturing sites and contract laboratories for Clinical biologics.
• Demonstrate a clear understanding of biological product testing methods and assays for effective troubleshooting, and remediation of atypical results.
• Act as an escalation point for complex/high impact quality control issues/decisions.
• Support identification, evaluation, selection, and management CMOs/CTLs, consultants etc. to control quality in support of achieving PDM’s strategic objectives.
• Establish clear expectations, metrics and KPIs, as appropriate to monitor QC operations and analytical method performance.
• Be accountable for reviewing data and troubleshooting analytical testing within the Biologics portfolio across internal and external partners.
• Monitor test method execution in QC laboratories to ensure methods are in a continuous state of control.
• Support validation of analytical methods for new Biologics programs and their transfer to outsourced partners to meet GMP testing needs.
• Contribute to Regulatory Filings, and responses to Information Requests from Regulatory Agencies.
• Interface with Regulatory agencies as required representing Gilead to authorities and regulatory inspectorates in matters relating to QC operations and stability studies.
• Lead or serve as a key project team member on large cross functional projects, often with high visibility to senior management within the organization or with international impact.
• Provide a long-term view to senior QC Leadership based on personal knowledge of the competitive environment.
• Support standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Control Systems

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees