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Gilead Sciences, Inc. Senior Manager, Compliance 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?

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, Foster City, CA, or remote.

Primary Responsibilities:

  • 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.

Qualifications:

  • 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 & 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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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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:

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.

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 a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.

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