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Gilead

Associate Director, Quality Assurance

For Current Gilead Employees and Contractors:

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

Job Description

Working in QA at Gilead:

Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going 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 QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Meet the worldwide QA Team: https://qualityassurance-careers.gilead.com/

Gilead Sciences is currently seeking an Associate Director, Quality Assurance in the Pharmaceutical Manufacturing and Development (PDM) organization at our Oceanside, CA location. The role is responsible for the administration of quality GMP operations and site Quality Systems at Oceanside (A biologic facility) This role will Manages QA personnel, including organizing and prioritizing group tasks, performing training, and writing performance reviews.

Job Responsibilities

  • Quality oversight & management of site operations and Quality System, including management of QA staff
  • Quality oversight of production, maintenance, engineering, automation, warehouse, supply chain, and validation functions
  • Timely review and approval of quality records
  • Management of batch record review, compilation, disposition of batches, site QMR/metrics, Training, risk management, and Self-Inspection.
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Participates in developing Standard Operating Procedures to ensure quality across internal and CMO operations
  • Maintains Quality Assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines.
  • Ensures that routine inspections are conducted of manufacturing areas, laboratories, warehouse, and utilities
  • Ensures compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Leads and manages internal compliance audits; provides support of external audits as required.
  • Work collaboratively with cross-functional teams across and responsible for decision-making on quality/compliance matters

Knowledge and Skills

  • Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
  • Demonstrates keen understanding of Equipment/Computer Systems Validation and ICH Guidelines.
  • Demonstrates excellent verbal, written and interpersonal communication skills.
  • Demonstrates knowledge of Six Sigma, Define-Measure-Analyze- Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical.
  • Demonstrates working knowledge of Risk Management tools (Failure Mode Effects Analysis (FMEA), Risk Ranking & Filtering (RR&F), Fault Tree Analysis, etc.).
  • Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager)

Requirements

  • Experience in a leadership role in Quality Assurance
  • Previous experience with Biologics a must
  • 10+ years of relevant experience in a GMP environment related field and a Bachelor’s degree in science or related fields.
  • 8+ years of relevant experience and a MS.
  • Knowledge and experience in quality assurance in a highly regulated manufacturing environment.
  • Prior people management experience.

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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.

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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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