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Gilead

Director , Quality Systems Training

For Current Gilead Employees and Contractors:

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

Job Description

Director, Quality Systems Training

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 a Director of Commercial QA, in the Pharmaceutical Manufacturing and Development (PDM) organization located in Foster City, CA. The role is responsible for the administration of quality standards and practices within a multi-national organization. This Quality professional will be a strategic leader in a cross-functional management team. In this position is you will provide consistent, effective and compliant oversight of commercial Contract Manufacturing Organizations (CMO) for Oral Solid Dosage (OSD) products, including manufacturing, packaging and labeling organizations.

Job Responsibilities

  • Leads the strategic planning process for PDM training and is responsible for its implementation.
  • Conducts training needs analysis and identifies performance gaps across PDM as required.
  • Performs a wide variety of activities to ensure compliance to applicable regulatory and quality systems requirements to facilitate compliance with regulatory agencies.
  • Develops, implements, and maintains Learning Management systems, programs and processes to ensure compliance with Current Good Manufacturing Practices (GMPs).
  • Serves as subject matter expert on best practices and new state of the art training delivery methodologies and curriculum development.
  • Serves as a change advocate to reinforce changes with senior managers and employees to support their own training needs
  • Reviews and approves training programs regarding implementation of quality systems.
  • Manages QA personnel, including organizing and prioritizing group tasks, training, writing performance reviews and guiding personnel in longer-term development.  
  • Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies as required.

Knowledge & Skills

  • Demonstrates in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally
  • Proven leadership skills with an ability to set a vision, to lead change, and to lead and mentor others.
  • Excellent communication skills, highly competent presenter, able to gain credibility, engender trust and influence all levels, strong partnering skills, bias for action and tangible results.
  • Excellent organizational skills, including ability to follow assignments through to completion with a bias towards execution
  • Demonstrates substantial knowledge of industry best practices and trends on Quality Systems and Training.
  • Is comfortable interacting with regulatory agencies as needed and possess the ability to represent Gilead in public forums.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.

Education & Experience

  • 10+ years of relevant experience in the pharmaceutical industry and a BS or BA.
  • Deep knowledge and experience in quality assurance in a highly regulated environment.
  • Prior people management experience.
  • Successful working experience in highly matrixed organizational structures.


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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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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