Director, Commercial Analytical Operations Biologics Quality Control

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Job description

Director, Commercial Analytical Operations Biologics Quality Control
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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

Director, Commercial Analytical Operations - Biologics Quality Control

KEY RESPONSIBILITIES:

The Director Commercial Analytical Operations is vital for the success of Commercial 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 commercial biologics drug substances and drug products. The role is accountable for refining QC procedures across Gilead's biologics manufacturing network, ensuring compliance with global cGMP and Gilead's Quality Management System. The Director 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 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 across all international affiliates, contract manufacturing sites and contract laboratories for commercial 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.
• Identify, select, manage, and evaluate 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 external network partners.
• Contribute to Annual Product Quality Reviews, 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.
• Lead standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Control Systems

REQUIREMENTS

You have:

• 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, creativity, and innovativeness.
• 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.

QUALIFICATIONS:

• Ph.D. with 8+ years experience OR M.S. with 10+ years experience OR B.S. with 12+ years industrial experience
• 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.

Gilead Core Values

Integrity (Doing What's Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

The salary range for this position is: $205,700.00 - $266,200.00. 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.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 for assistance.

For more information about equal employment opportunity protections . click apply for full job details

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