Sr Manager, Quality Assurance

Sr Manager, Quality Assurance
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.

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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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Job Description


Role and Responsibilities:

Gilead Sciences is currently seeking an Sr. Manager, Quality Assurance- DCQA Parenterals Dept, in the Pharmaceutical Manufacturing and Development (PDM) organization located in Foster City, CA. The role is responsible for quality oversite of clinical development and commercial programs and batch disposition.

Essential Duties and Job Functions:

• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements in support of Clinical Parenteral and commercial programs.
• Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
• Implements and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products, including master batch records, executed batch records, deviations and change controls.
• Responsible for final release of manufactured products and labeled clinical supplies.
• Works extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.
• May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
• Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products including laboratory investigations. May assist in compliance audits as required.
• Interfaces with contract manufacturers to address and resolve more complex product/process performance issues.
• Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes and Manufacturing on commercial products.

Knowledge and Skills:

• Demonstrates in-depth knowledge of GMPs and/or GLPs.
• Demonstrates in-depth knowledge of parenteral manufacturing.
• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes and drives continuous improvement initiatives.
• Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.

Preferred Skills:

• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
• Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.
• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.
  

Education and Experience:

• 8+ years of experience in a GMP environment related field and a BS or BA Or 6+ years of relevant experience and a MS.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical 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.

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.

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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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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