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Manager, Quality Assurance

Employer
Gilead Sciences, Inc.
Location
Foster City
Salary
See job description.
Closing date
Feb 4, 2021

View more

Discipline
Other, Manufacturing/QA/QC
Position Type
Full Time
Job Type
Manager
Organization Type
All Industry, Pharma


Manager, Quality Assurance
Canada - Ontario - Mississauga

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. Gileads 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 companys five core values. Thats 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



  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
  • Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met.
  • Maintains programs and processes to ensure high quality products and compliance with Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
  • Works closely 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.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  • Works with Research and Development during new product start-ups and establishes key checkpoints for new products and processes.
  • May assist or lead compliance audits as required. May interface with regulatory agencies as required.
  • Interfaces with contract manufacturers to address documentation and compliance issues.


Critical Competencies:
  • 7+ years of relevant experience in a GMP environment related field and a B.Sc. degree in science related area to the work being carried out.
  • 5+ years of relevant experience and a MS Proficient in GMPs and/or GLPs.
  • Proficient in application of QA principles, concepts, industry practices, and standards.
  • Demonstrates ability to effectively manage multiple projects/priorities.
  • Has proven analytical and conceptual skills.
  • Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
  • Demonstrates excellent verbal communication, technical writing and interpersonal skills.
  • Demonstrates working knowledge and good proficiency in Microsoft Office applications.
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
  • Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA) is beneficial



For Current Gilead Employees and Contractors:

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


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/Canada---Ontario---Mississauga/Manager--Quality-Assurance_R0016238-2





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