Gilead Jobs

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Job Description

Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs?

R&D Quality and Medical Governance is seeking a Director, R&D Audit Program - IT Systems to join our Leadership Team that is responsible for the Gilead R&D GxP Audit program.

In this role you will be responsible for all GxP audit activities for IT Systems, related vendors and service providers across R&D. The purpose of this position is to assure compliance with GxP and data integrity throughout the data life cycle.

Primary Responsibilities

• Perform risk assessments for GxP relevant IT Systems, related vendors and service providers across R&D

• Using a risk-based approach, lead the development of the annual R&D audit plan for GxP relevant IT Systems, related vendors and service providers

• Execute against the annual audit plan with the orchestration of internal and external auditors

• Develop detailed audit execution plans

• Conduct audits according to approved audit execution plans

• Generate audit reports and communicate observations to relevant parties

• Approve audit responses and ensure execution of corrective and preventive actions

• Provide metrics for effective reporting of audit observations

• Identify and communicate trends for robust mitigation

• Drive for a state of inspection readiness across R&D for GxP relevant IT Systems, related vendors and service providers

• Provide guidance on GxP and relevant IT regulations for internal stakeholders

• Cultivate and maintain strategic relationships and collaborations both internally and externally

• Support overall R&D Quality & Medical Governance goals

• Train and manage internal staff

• Lead intra or interdepartmental teams such as improvement initiatives

• Foster a commitment to quality and a culture of quality within the organization

• 12+ Years with BA/BS or 10+ Years with MA/MS/MBA or 8+ Years with PharmD/PhD

• Extensive experience leading GxP IT System audits in R&D in the biopharma industry

• Expert knowledge with 21 CFR Part 11 electronic systems and compliance

• Experience in implementing principles for Quality Risk Management

• Significant experience leading cross functional projects and teams

• Strong verbal and written communication skills and interpersonal skills

• Excellent organizational and project management skills

• Ability to travel approximately 20-30% required.

About Gilead R&D Quality and Medical Governance

Gilead R&D Quality and Medical Governance is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team.

We are a committed team of highly skilled Quality and Medical Governance professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.

We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.

Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?

The salary range for this position is: $199,835.00 - $258,610.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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.

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For Current Gilead Employees and Contractors:

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Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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