Senior Manager, Clinical Compliance, R&D Quality and Compliance
Senior Manager, Clinical Compliance, R&D Quality and Compliance (New Jersey, Seattle, WA, Foster City, CA)
United States - California - Foster CityUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle
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
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 Clinical Quality and Compliance Sr. Manager who is ready to dive-in to support our clinical development programs. As a Clinical Quality and Compliance Sr. Manager, you will support and work with our clinical study management teams and teammates across R&D Quality and Compliance.
We need someone with strong Good Clinical Practice (GCP) knowledge, audit skills, communication, and facilitation skills, and the ability to manage multiple projects. You will be a part of an expert and supportive team that fosters constructive collaboration in support of our clinical development programs.
**Note: This role can be based in New Jersey, Seattle, WA or Foster City, CA.**
- Serve as Clinical Compliance Lead for assigned clinical trial programs. Handle multiple projects and ensure overall and timely completion of tasks.
- Leads development of audit plan for assigned projects and manages audit plan execution.
- Manages and/or leads GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
- Trains and manages contracts auditors.
- Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
- Assists in readiness preparation, and/or directly support regulatory agency inspection. Assist in coordination of response to any findings.
- Support deviation identification, reporting, and CAPA development
- Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
- Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS).
- Fosters a commitment to quality in individuals and a culture of quality within the organization.
- BA or BS and 8+ years of relevant experience (6+ years of relevant experience with an applicable MS).
- At least 5 years of audit and compliance experience. Must have significant GCP audit and compliance experience. Bio-pharma sponsor experience required.
- Recognized as an expert resource on a range of clinical compliance topics.
- Strong verbal and written communication skills and interpersonal skills.
- Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
- Excellent organization skills and project management.
- Able to work equally well as part of a team or independently
- Ability to travel approximately 25% 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 email@example.com 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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