Associate Director , Quality Control (Biologics Analytical Operations)

Location
Oceanside, CA, United States
Posted
Jul 09, 2021
Ref
2216907
Required Education
Bachelors Degree
Position Type
Full time
Associate Director , Quality Control (Biologics Analytical Operations)
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 #CreatingPossible

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Essential Duties and Job Functions:
  • 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.
  • 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 audits as required.


Knowledge, Experience and Skills:
  • Bachelor's with 10+ years or Master's degree with 8+ years of relevant biotech/pharmaceutical professional experience in the analytical chemistry, biochemistry, microbiology, pharmacology or a related discipline from an accredited university.
  • 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)
  • Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality Control and outside of the function.
  • 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.


Additional Experience and Skills:
  • 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.
For jobs in the United States:
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.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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