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Gilead Sciences, Inc. Executive Director, Quality Process, Documentation and Learning in Morris Plains, New Jersey

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

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 Executive Director, Process, Documentation and Learning to join our Leadership Team. In this role you will lead a team that provides the GCP, GLP and GVP Quality framework for process development, controlled documentation and learning programs. Providing global strategic direction and leadership, your team will partner closely across R&D in applying a process framework, documentation architecture and learning mindset for internal and external staff supporting R&D. In addition, this role leads the provision of documentation and training coordination in the respective Part 11 validated electronic systems. You will also be a key member of the R&D Quality and Medical Governance Leadership Team advancing a culture of Quality and integrity across Gilead.

We seek an individual with strong leadership skills, expert knowledge of the regulations governing drug development and post marketing activities as well as deep understanding of effective learning paradigms.

You will be a part of an expert global Quality leadership team that strives to be a trusted business partner and promotes a culture of Quality in all we do.

Primary Responsibilities

Envision, build and maintain a comprehensive process, documentation and learning program to meet the GxP and Medical Governance needs of the R&D organization. Establish and maintain a process architecture model and technologies that connects drug development and Medical Affairs processes. Structure and oversee application of the controlled document hierarchy across R&D, enabling consistent use of document types that focus on ease of use for the end-user and assure compliance. Enable authoring of controlled documentation with technical writing capabilities. Serve as an ambassador of Good Documentation Practices that assure GxP compliance and data integrity. Ensure periodic review of documents and provide mechanisms to track changes and remain current with regulatory guidance. Establish change management capabilities to assure stakeholder awareness of process, documentation and learning program changes. Ensure that compliance focused and GxP-required training is enabled via targeted role-based curricula. Enable onboarding and development via role-based learning programs for R&D Quality and Medical Governance. Establish forums for curricula owners to maintain, periodically review curricula, alerting management to gaps in completion of assigned training, and managing training related documentation. Determine process, documentation and learning Quality metrics and analytics to enable oversight and reporting to functional management and Gilead leadership. Leverage risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. Serve as an expert and provide guidance on and interpretation of global GLP/GCP/GCLP/GVP regulations, standards and quality systems related to process, documentation and learning for internal stakeholders Interface with key internal business stakeholders and external groups including PDM Quality, CONNECT, BRIDGE, Kite R&D Quality and Compliance and other Gilead organizations. Support overall R&D Quality & Medical Governance goals and objectives including but not limited to resource budget and outputs, and line management oversight of the team. Supervise, develop, train and manage internal staff. This includes fostering a commitment to quality in individuals and a culture of quality within the organization. Lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management as needed. Lead intra or interdepartmental teams such as continuous improvement initiatives.

Qualifications

  • Bachelor’s degree with 15+ years; Master’s degree with 12+ years; or PhD with 10+ years of R&D quality assurance compliance experience.

  • Broad GLP/GCP/GCLP/GVP quality system and compliance experience.

  • Organizational design and transformation leadership experience.

  • Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required.

  • Familiarity with 21 CFR Part 11 electronic systems and compliance activities is preferred.

  • Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R2) preferred.

  • Experience leading business process improvement projects required. Lean Six Sigma Green/Black Belt preferred.

  • Proven effective verbal, written, interpersonal skills to include delivering presentations to executives.

  • Recognized as an expert resource on a range of compliance topics.

  • Management of junior and senior staff with track record of capability development.

  • Demonstrated effective verbal and written communication skills.

  • Proficient in Microsoft Office suite.

  • Experience with Audit management/CAPA management programs strongly preferred.

  • Excellent organizational and project management skills.

  • Able to lead and mentor effective cross functional teams.

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 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?

For Colorado Job Applicants: The salary range for this position is:

$221,600.00 - $332,400.00

Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.

Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

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