Leading GCP audit activities for Clinical Investigator sites, related processes and vendors across R&D. The purpose of this position is to assure compliance with GCP across Gilead R&D Programs. Primary Responsibilities. Using a risk-based approach, lead the development of the annual R&D audit plan for GCP Investigator Sites and Internal processes. Execute against the annual audit plan with the orchestration of internal and external auditors. Develop detailed audit execution plans. Conduct audits... more details
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Please log onto your Internal Career Site to apply for this job.
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
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 is seeking a Director, R&D Audit Program - GCP to join our Audit, Inspection and CAPA Management Team that is responsible for the Gilead R&D GxP Audit program.
In this role you will be responsible for leading GCP audit activities for Clinical Investigator sites, related processes and vendors across R&D. The purpose of this position is to assure compliance with GCP across Gilead R&D Programs.
Primary Responsibilities
Using a risk-based approach, lead the development of the annual R&D audit plan for GCP Investigator Sites and Internal processes.
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
Approves audit reports when needed
Oversee external consultants and audit partner activities for quality deliverables.
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 Gilead’s clinical programs.
Provide guidance on GCP and relevant regulations for internal stakeholders
Cultivate and maintain strategic relationships and collaborations both internally and externally
Support overall R&D Quality 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
Requirements:
12+ Years with BA/BS or 10+ Years with MA/MS/MBA or 8+ Years with PharmD/PhD
Extensive experience leading GCP Audits (vendor, investigator site, phase 1 units and internal process/function audits) in R&D in the biopharma industry
Expert knowledge of the drug development process and GxP, including worldwide regulations and their application to cross-functional drug development.
Demonstrates ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross- functional peers and more senior management levels.
Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner across functions.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
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
Gilead R&D Quality 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 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: $205,700.00 - $266,200.00. 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.
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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 ApplicantAccommodations@gilead.com for assistance.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
