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Gilead

Director, Compliance

For Current Gilead Employees and Contractors:

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

Job Description

Specific Job Responsibilities:

  • Immediate area of responsibility is Electronic Systems Compliance; experience in clinical compliance, laboratory compliance, or pharmacovigilance also required.
  • Leads efforts to increase the commitment to quality in individuals and a culture of quality within the organization.
  • Provides compliance guidance and quality oversight to project teams implementing electronic systems in a variety of regulatory environments.
  • Provides guidance and leadership to junior staff also involved in regulated electronic systems implementation projects.
  • Work is performed under consultative direction towards corporate and department goals and objectives.
  • Supervises the prioritization and coordination of the work of others.
  • Ensures annual audit plans are developed and audit activities are completed according to plan across sites.
  • Monitors resources and budget for audits.
  • Identifies new contract auditors, oversees the establishment of agreements and ensures all commitments are met by contract auditors.
  • Responsible for the oversight of SOP evaluation and implementation.
  • Keeps a watch toward changes in industry/regulatory environment that would necessitate future changes and proactively initiates discussions so the company is prepared to respond to such changes.
  • Contributes to or leads intra- or interdepartmental teams of a strategic nature such as: defining the direction of the Company in response to industry or regulatory initiatives, implementing company-wide Quality Management or computer systems.
  • May lead management of regulatory agency inspections and coordination of responses to any regulatory agency findings.
  • Anticipates training requirements based on business needs and evolving regulatory expectations.
  • May act as a change agent on projects which have strategic impact on the organization.
  • Acts as a role model for change by demonstrating commitment to changes.
  • Considers a number of factors in planning, anticipating and prioritizing work to meet tight timelines.
  • Assists in developing strategic plans for business areas that contribute to organizational goals.
  • Contributes to establishing compliance quality standards.
  • Checks perspective of others and adapts communication approach accordingly.
  • Builds positive support for compliance positions outside of formal meetings.
  • Determines most efficient and appropriate method of communication in a variety of situations.
  • Understands impact of decisions and actions on business and consults with appropriate colleagues and management.
  • Promotes and maintains productive working relationships.
  • Mentors others in establishing good working relationships.
  • Addresses sensitive issues in an objective manner.
  • Must have a highly developed knowledge of regulatory requirements for assigned projects.
  • Is recognized as a knowledgeable resource within the department and in supported departments on a range of topics and is someone whose opinion is sought as a regulatory compliance resource.
  • Understands current global and regional trends in regulatory compliance and has the ability to assess the impact of these requirements to the business.

Specific Education & Experience Requirements:

  • 12+ years of relevant experience and a BS.
  • 10+ years of relevant experience and an MS.
  • Relevant work experience consists of working in a pharmaceutical quality control, quality assurance, information technology, or compliance environment.

Meet the team:

https://regulatoryaffairs-careers.gilead.com/

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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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