Executive Director, Quality Product Lead, External Quality

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
 

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Working in QA at Gilead:

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

Job Summary:
Gilead Sciences is currently seeking an Executive Director level position to be the leader of Quality Product Lead (QPL) Team, External Quality Operations, in the Pharmaceutical Development and Manufacturing (PDM) organization. The QPL is a strategic matrixed leadership position responsible for the overall product quality strategy. The leader of QPL is a key strategic member of Quality Assurance management team in continually assessing quality systems, providing guidance and direction for implementation of effective and efficient quality processes. The candidate must have demonstrated leadership skills and with in-depth understanding of drug development, commercialization, and lifecycle management, be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact to the business and be able to partner with leaders in Portfolio Strategy team, Manufacturing, Technical and Analytical functions, Supply Chain, Regulatory CMC, and the wider PDM Quality organization to achieve business objectives.  The successful candidate must have proven track records in leading technical teams in a biotech or pharmaceutical development environment and strong knowledge of cGMP quality systems.

Job Functions:

• Execute an integrated and sustainable external quality strategy and company content priorities for Gilead’s clinical and commercial products and contract organizations based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs.
• Develop processes to communicate learnings and drive any related activities for Gilead’s clinical and commercial products in support of a robust compliant lifecycle for the programs.
• Develop a process for exchange of lessons learned across multiple company representatives and identify opportunities for Gilead’s process improvements.
• Collaborate with Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements.
• Implement continuous improvement initiatives to drive quality programs and ensure maximum productivity. Ensure systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
• Develop, implement, and monitor quality programs, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines.
• Set and drive compliance to department, site and global KPIs.
• Evaluate all current quality systems and processes and recommend and implement appropriate enhancements and trainings to ensure the achievement of Gilead long-term objectives.
• Professional organization engagement and representation; benchmarking in industry networks.
• Provide guidance to the business teams on technical regulatory requirements and lead and assist where needed.
• Participate on the Product and Network Governance Committee (PNGC), Joint Steering Committees (JSC) and Joint Management Committees (JMC) as Quality’s voice for the product.
• Contribute to and review regulatory dossier sections and information requests (including but not limited to IND, IMPD, BLA, NDA, MAA, post-approval changes and post marketing commitments).
• 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.
• 15-20% travel based on strategic plan.

Knowledge, Experience and Skills:

• In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally.
• Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality.
• Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product.
• 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.
• Ability to interact with regulatory agencies as needed and possesses the ability to represent Gilead in public forums.
• Demonstrated experience and ability to manage team of highly technical staffs.
• Expert in managing resources to address competing projects and timelines.

Basic Qualifications:

• 12+ years of relevant experience and a bachelor’s degree in science or related fields; or 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
• Prior leadership experience in a complex organization a must.
• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
• Biopharmaceutical or Pharmaceutical experience a must.
• Broad experience across contract organization management, quality assurance, validation, drug development and product lifecycle management preferred.
• Experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred.

The salary range for this position is: $281,010.00 - $363,660.00. 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.

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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 ApplicantAccommodations@gilead.com for assistance.
 

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For Current Gilead Employees and Contractors:

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