Senior Manager, R&D Quality and Compliance (Electronic Systems Compliance)
Senior Manager, R&D Quality and Compliance (Electronic Systems 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. Gileads 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 companys five core values. Thats 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
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 Senior Manager 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.
- Immediate area of responsibility is Electronic Systems Compliance and QA Lead for assigned functional areas. Experience with clinical and/or pharmacovigilance systems is preferred.
- Provides compliance guidance and quality oversight to project teams implementing electronic systems in a variety of regulatory environments. Work closely with the Business 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.
- Review and approval of computer system validation deliverables. Support Deviation identification, reporting, and CAPA development.
- Contributes to intra- or interdepartmental teams of a strategic nature such as: defining the compliance direction to the business teams while implementing GxP systems.
- Fosters a commitment to quality in individuals and a culture of quality within the organization
- Builds positive support for compliance positions outside of formal meetings.
- Train intra- or interdepartmental teams on validation and electronic system compliance related topics.
- Participate in the qualification of vendors and conducting ongoing audits utilizing a risk-based approach.
- Participate in internal process and systems audits.
- Assists in readiness preparation, and/or directly support regulatory agency inspection. Assist in coordination of response to any findings.
- 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.
- Represent R&D Quality and Compliance in internal and external meetings.
- BA or BS and 8+ years of relevant experience (6+ years of relevant experience with an applicable MS).
- Relevant work experience consists of working in a pharmaceutical quality control, quality assurance, information technology, or compliance environment.
- Must have significant experience with implementing and validating regulated systems (COTS, SaaS, Bespoke).
- Strong working knowledge in risk-based validation methodology (GAMP 5), software development lifecycle (SDLC).
- Comprehensive expertise and working knowledge of GxP including 21 CFR Part 11, Annex 11, and data integrity requirements.
- Experience with safety, clinical and regulatory information systems preferred.
- Experience with auditing vendors providing systems, software and other relevant services.
- Strong verbal and written communication skills and interpersonal skills.
- Proficient in Microsoft Office suite.
- Excellent organization skills and project management.
- Able to work equally well as part of a team or independently.
- Ability to travel approximately 20% required.
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?
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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 firstname.lastname@example.org 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:
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