Director, Quality Control

Director, Quality Control
United States - New Jersey - Morris Plains

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 #CreatingPossible


Director Quality Control, Biologics Analytical Operations

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.

The successful candidate will possess a detailed understanding of Quality Control in support of large molecule manufacturing as well as demonstrated success in organizational leadership and building high performing teams. The candidate must be highly motivated to contribute to the development of biologics targeting unmet medical need through the establishment and leadership of a team supporting multiple clinical and commercial programs. This role will have responsibility for supporting GMP activities at internal production sites as well as multiple external contract testing sites, internal and external method establishment, product performance monitoring, existing methods and specifications, reference standard programs, QC impacting change controls, and analytical investigation oversight.

Essential Duties and Job Functions:

• Drive strategic decisions on product quality and Quality Control quality systems and implement appropriate processes in support of these.
• Actively manage partnerships with internal key stakeholders and external testing organizations to achieve business objectives.
• Manages the Quality Control product quality function, ensuring processes provide high quality analytical support for internal and external production, product monitoring and trending, and collaboration with process and analytical development while ensuring compliance of protocols, GMP's, and safety regulations.
• Own and direct efforts in support of Quality Systems records, deviations, CAPAs, and change controls.
• Leads and represents QC requirements on multiple projects.
• Actively manages a group of QC personnel and oversees their performance management, mentoring, and career development in line with individual strengths.
• Works with Regulatory & Quality Assurance to ensure that all procedures and applicable regulatory requirements are followed and properly documented.
• Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.
• Must be able to analyze process, lead improvement activities, and empower staff to create a lean culture in the laboratory.
• Has a strong grasp of the underlying science but able to take on additional operational responsibilities because of talent and indicated interest.
• Serves as a resource to management on the operational strategy of the research function and provides long term resource planning
• Excellent scientific and business communication skills (both verbal and technical) and interpersonal skills are required.
• Works on a wide range of problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.
• Will work on more complex problems where analysis of situations or data requires in-depth evaluation of various factors, strong judgment is required in resolving problems and making recommendations - typically high impact issues that have implications across functions.
• Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality Control and outside of the function.
• Demonstrated ability in integrating varied concepts and data to develop relevant solutions
• Demonstrated ability to create an energizing team environment
• Demonstrated ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
• Supports and/or coordinates internal and external regulatory audits as required.

Knowledge, Experience and Skills

• Bachelor's or master's degree in the analytical chemistry, biochemistry, microbiology, pharmacology or a related discipline from an accredited university.
• Bachelor's degree will possess 20+ years of relevant biotech/pharmaceutical professional experience.
• Master's degree will possess 15+ relevant biotech/pharmaceutical professional experience.
• Well qualified candidates with differing levels of experience are also encouraged to apply and may be considered for other positions.
• Excellent communication skills (both verbal and technical) and interpersonal skills are required.

• Demonstrated people management skills required
• In-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
• In-depth knowledge of QC principles, concepts, industry practices, and standards
• Keen understanding of international quality control systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
• Knowledge and experience in commercial Quality Control in a highly regulated manufacturing environments is preferred

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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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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