Director, R&D Quality and Compliance

Director, R&D Quality and Compliance
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Title:

Director R&D, Quality and Compliance (Electronic Systems Compliance and Data Integrity)

Job Description:

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 healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in 35 countries worldwide, with headquarters in Foster City, California.

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? We are looking for a Director R&D Quality and Compliance, to provide quality and compliance oversight for regulated computerized systems. This position is responsible for assuring that systems are validated in compliance with regulatory requirements, computer system validation procedures and data integrity requirements. We need someone with a strong understanding of risk-based computer system validation, audit skills, communication and facilitation skills, and the ability to manage multiple projects. In addition, experience with GCP, PV and/or GLP is preferred.

Specific Job Responsibilities:

• 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.
• Work closely with the Business Process Owners and IT to ensure deployment of GxP systems meets company standards, relevant regulations, such as 21 CFR Part 11 and Annex 11, and that systems are maintained in a validated state.
• Development of system specific validation plans and strategy.
• Review and approval of computer system validation deliverables.
• Provide training on validation and electronic system compliance related topics to colleagues across the globe.
• Responsible for development and implementation of electronic system compliance and data integrity related procedures to ensure company practices meet regulatory requirements and follow industry best practices.
• Provides guidance and leadership to junior staff also involved in regulated electronic systems implementation projects.
• Supervises the prioritization and coordination of the work of staff and/or consultants.
• Ensures annual audit plans are developed and audit activities are completed according to plan across sites.
• Participate in the qualification of vendors and conducting ongoing audits utilizing a risk-based approach.
• Participate in internal process and systems audits.
• Assist in inspection readiness preparation, management of regulatory agency inspections and coordination of responses to any regulatory agency findings.
• Maintain up-to-date on changes in industry/regulatory environment that would necessitate future changes and proactively initiates discussions, so the company is prepared to respond to such changes.
• Understands current global and regional trends in regulatory compliance and has the ability to assess the impact of these requirements to the business.
• 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.
• Assist in inspection readiness preparation, management of regulatory agency inspections and coordination of responses to any regulatory agency findings.
• May act as a change agent on projects which have strategic impact on the organization.
• Represent R&D Quality and Compliance in internal and external meetings.
• 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 with staff and functional areas.
• Addresses sensitive issues in an objective manner.

Qualifications:

• BS or equivalent degree.
• 10+ years of relevant experience in a pharmaceutical quality control, quality assurance, information technology, or compliance environment.
• Significant experience with implementing and validating regulated systems (COTS, Saas, Bespoke) required.
• Experience with auditing vendors providing systems, software and other relevant services.
• In-depth knowledge of GAMP 5 and software development lifecycle methodologies, testing best practices and computer software assurance.
• Extensive understanding of 21 CFR Part 11, Annex 11, and Data Integrity requirements.
• Experience with clinical, safety and regulatory information systems preferred.
• Strong project management skills with the ability to prioritize and adapt to business needs while upholding compliance with regulations and company procedures.
• Excellent written and verbal interpersonal communication skills.
• Ability to travel up to 20%.

About Gilead R&D Quality and Compliance

Gilead R&D Quality and Compliance 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 Compliance 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 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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