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Gilead

Senior Manager, Laboratory Compliance

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Senior Manager, Laboratory Compliance

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 Laboratory Compliance Senior Manager who is ready to dive-in to support our drug development programs and work with our pre-clinical and clinical study management teams and teammates across R&D Quality and Compliance.

We need someone with practical working knowledge of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) as it applies to areas such as bioanalytical, biomarkers, clinical (central) labs, and early phase clinical trial.  Strong audit skills, and the ability to manage multiple projects are key to success in this position. You will be a part of an expert and supportive team that fosters constructive collaboration in support of our drug development programs.

*ROLE CAN BE BASED IN SEATTLE, WA OR FOSTER CITY, CA *

Primary Responsibilities

  • Leads the development of annual audit plans for assigned projects associated with but not limited to internal processes, and vendors.
  • Manages audit plan execution and monitors resources and budget for audits.
  • Leads and/or manages internal and external laboratory audits. Conducts study specific audits (e.g. data, report, central labs, critical phase) and equipment validation deliverables review. Perform audits of processes and business practices within the company.
  • Identifies new contract auditors, oversees the establishment of agreements and ensures all training and commitments are met by contract auditors.
  • Works closely with clinical and pre-clinical study management teams to provide expert laboratory compliance and industry standards information, manage identified issues, and support continuous improvement.
  • Assists in readiness preparation of regulatory agency inspection and assist in the coordination of response to any findings.
  • Responsible for identifying and escalating issues and risks to management, as appropriate
  • 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).
  • Supervises the coordination of the work of others and participates as the Laboratory Compliance stakeholder in relevant working groups.
  • Execute study quality metrics actions.

Qualifications

  • BA or BS and 8+ years of relevant experience (6+ years of relevant experience with an MS).
  • Demonstrated knowledge of clinical lab compliance, and early phase research compliance.  Preclinical compliance knowledge and experience strongly desired.
  • Must have significant GCP and/or GLP audit experience.
  • Working knowledge of protein, genetic, genomic and cellular and/or cellular biomarker and/or bioanalytical technologies desired.
  • Strong verbal, written and interpersonal communication skills.
  • Proficient in Microsoft Office suite. Experience with electronic record management, audit management/CAPA management programs strongly preferred.
  • Ability to manage multiple projects and ensure overall and timely completion of tasks.
  • Able to work equally well as part of a team or independently.
  • Ability to travel approximately 25% as required.

About Gilead R&D Quality and Compliance

The Gilead Laboratory Compliance team is a phenomenal place to develop your skills and expertise. Gilead’s 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.

RSRGIL


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.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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 to apply for this job.

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