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Manager, Quality Systems

Employer
Gilead Sciences, Inc.
Location
Oceanside
Salary
See job description.
Closing date
Mar 28, 2021

View more

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

 


Manager, Quality Systems
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. 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


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 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 Manager Quality Systems oversees the site quality systems, programs (specifically training and audits), and overall improvement efforts. This role also manages a team who supports the training and audit activities at the site.

Responsibilities also include:

 

 

  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Manages and oversees Site training program, personal, metrics, and reporting functions to Site and Corporate.
  • Manages, Schedules, and Leads the Site Internal Audit Program, as well as supports Corporate initiatives for supplier audits. May interface with regulatory agencies as required.
  • Maintains and leads site Quality Management Review and presentations
  • Maintains programs and processes for Supplier Change Notifications and Quality Agreements
  • Participates in writing or suggesting changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements - supervises QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
  • 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 conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  • Actively pursues opportunities for improvement and promoting a strong culture of quality awareness and GMP compliance.
  • Works with Research and Development during new product initiations and establishes key checkpoints for new products and processes.
  • Interfaces with contract manufacturers to address documentation and compliance issues
  • May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.


Knowledge & Skills

 

 

  • Proven ability to lead or manage teams
  • Proven ability to effectively manage multiple projects/priorities.
  • Demonstrates working knowledge and good proficiency in ERP systems (Oracle, SAP, LIMS)
  • Proficient in GMPs and/or GLPs. (CFR's 210, 600, 820)
  • Proficient in principles of CAPA and Deviation executions and investigations
  • Proficient in application of QA principles, concepts, industry practices, and standards.
  • Proficient in Quality Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA))
  • Proficient in creations and presentation of site and corporate metrics
  • Has previous working experience with manufacturing operations and associated support functions (Chemistry/Micro/Facilities)
  • Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
  • Demonstrates excellent verbal communication, technical writing and interpersonal skills.
  • Demonstrates excellent skills in conducting and presenting training to personnel
  • 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 is beneficial.


Education & Experience

7+ years of relevant experience in a GMP environment /related field and a BS or BA.

5+ years of relevant experience in a GMP environment /related field and a MS.

Preferred background and/or knowledge in operations supporting biologics manufacturing/production.

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.

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.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Oceanside/Manager--Quality-Systems_R0016794-1





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