Director, Quality and Compliance, (GCLP, GCP, GLP) - Foster City, CA & Seattle, WA

Location
Foster City
Salary
See job description.
Posted
January 22 2021
Ref
R0017023
Discipline
Other, Science Policy
Position Type
Full Time
Organization Type
Pharma


Director, Quality and Compliance, (GCLP, GCP, GLP) - Foster City, CA & Seattle, WA
United States - California - Foster CityUnited 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 an expert Quality Assurance Professional with Good Clinical Laboratory Practices (GCLP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) experience who is ready join our Global R&D Quality and Compliance (Q&C) team. As a member of the global Quality and Compliance management team you will provide leadership and subject matter expertise with-in Q&C as well as to other key functional stakeholders for clinical development programs at Gilead. In addition, you will support other strategic activities of the Q&C group such as Internal Process Audits, Vendor Audits and Health Authority Inspections.

This role is suited to candidates who possess strong leadership skills and strategic risk-based thinking. Utilizing expert GCLP, GCP and GLP knowledge this role will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization. You will be a part of an expert team supporting compliance in preclinical and clinical development programs at Gilead.

** This position would be open to applicants interested in Foster City, CA or Seattle, WA location. **

Primary Responsibilities
  • Advance the understanding of laboratory data in support of clinical development programs and the regulatory framework to ensure data integrity and patient safety.
  • Act as strategic adviser for the Gilead Clinical Pharmacology, Biomarker Science and Biomarker operations teams for matters related to regulatory compliance.
  • Support the Gilead Biologic Sample Management Team in matters related to regulatory compliance including informed consent.
  • Act as subject matter expert for Quality & Compliance in supporting laboratory risk assessments and audit strategy including Phase 1.
  • Provide timely risk-based compliance advice that facilitates decision making.
  • Active member of the Global R&D Quality & Compliance Management team
  • Represent Quality & Compliance in lab related and other GCP working groups and initiatives as appropriate
  • Effective compliance reporting to senior management and relevant quality governance forums.
  • Investigate important compliance Issues
  • Support CAPA development & effectiveness checks of CAPAs for internal deviations and vendor audits.
  • Support regulatory agency inspections of Gilead as needed.
  • Supervise, develop, train and manage internal staff as appropriate.
  • Fosters a commitment to quality in individuals and a culture of quality within the organization.
  • Evaluate departmental and business area SOPs for fitness for purpose and for compliance with regulatory requirements.
  • Provide Q&C input on new SOPs, often regarding complex processes entailing complicated cross-functional work and inter business partner relationships.
  • Lead/support continuous improvement of and ensure adherence to departmental SOPs across sites.
  • Lead intra or interdepartmental teams of an operational nature such as preparing Gilead minor changes in regulations, and continuous improvement initiatives.


Qualifications
  • BA or BS and 10-12+ years of relevant experience (10+ years of relevant experience with an MS).
  • Must have significant GCLP and GCP audit experience, and as a senior compliance adviser.
  • Experience related to Phase 1 Units, especially PK/PD sample handling: chain of custody, sample storage on-site and then when transporting to labs, and then through the receipt, testing and storage of the samples at the lab.
  • GLP compliance experience preferred
  • Bio-pharma sponsor experience required.
  • Recognized as an expert resource on a range of compliance topics.
  • Strong verbal and written communication skills and interpersonal skills.
  • 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?


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.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Director--Laboratory-Compliance--Quality-and-Compliance_R0017023-2





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