Associate Director, Commercial Quality Control
United States - California - Oceanside
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 #CreatingPossibleFor Current Gilead Employees and Contractors:
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to apply for this job.Job Description
The successful candidate will possess a detailed understanding of Quality Control in support of large molecule manufacturing. The candidate must be highly motivated to contribute to the development of biologics targeting unmet medical need through the establishment and leadership of a high performing team supporting commercial programs. This role will have responsibility for the execution of required QMS activities that pertain to commercial operations.Essential Duties and Job Functions:
Education, Experience and Skills:
- Manages the Commercial Quality Control QMS operations group (Change Control, CAPA, Deviations and Investigations).
- Leads and represents Commercial QC requirements on multiple projects and teams, supporting ongoing QMS activities resulting from internal and external activities.
- Works with Regulatory & Quality Assurance to ensure that all procedures and applicable regulatory requirements are followed and properly documented.
- Provides Quality Control administration of investigations, change controls and impact assessments.
- 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.
- Supports and/or coordinates internal and external regulatory and supplier quality audits, as required.
- Leads process improvement activities and lean exercises for Commercial QC
Additional Experience and Skills:
- Bachelor's OR Master's degree in the biology, biochemistry, microbiology, pharmacology or a related discipline from an accredited university, with 10+ (Bachelor's) OR 8+ (Master's) years of relevant biotech/pharmaceutical experience
- Excellent communication skills (both verbal and technical) and interpersonal skills are required.
- Demonstrated project management skills required
- In-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
- 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.
- 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
- Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality Control and outside of the function.
- LSSBB preferred
- Knowledge and experience in commercial Quality Control in a highly regulated manufacturing environments is preferred
- 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.
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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 email@example.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., Canada, Australia, Singapore, and Hong Kong 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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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.