Sr. Manager Compliance- GCP - Foster City, CA | Biospace
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Sr. Manager Compliance- GCP

Gilead Sciences, Inc.

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Location:
Foster City, CA
Posted Date:
7/12/2017
Position Type:
Full time
Job Code:
34448
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Compliance, Manager,

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. We strive to transform and simplify care for people with life-threatening illnesses around the world. Gilead's portfolio of products and pipeline of investigational drugs includes treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular conditions.

Areas of responsibility include:

-Clinical Compliance.

-Fosters a commitment to quality in individuals and a culture of quality within the organization.

-Work is performed under limited supervision. Minimal instruction is required only occasionally. Establishes and implements new tools as necessary.

-Coordinates and reviews the work of others.

-Manages and/or leads others in both routine and complex audit activities involving multiple projects and is responsible for ensuring activities are completed.

-Identifies, defines and communicates audit plans for contract auditors and oversees the activities performed by contract auditors. Trains contract auditors in company procedures.

-May establish relationships and agreements with contract auditors.

-Evaluates departmental and business area SOPs for fit for purpose and in compliance with regulatory requirements.

-Leads intra- or interdepartmental teams of an operational nature such as: preparing the Company for minor changes in regulations, continuous improvement initiatives

-Purpose is for input and obtaining information for dissemination intra- or interdepartmentally.

-Assists in readiness for and regulatory agency inspections. Assists in the coordination of responses to any regulatory agency findings.

-Developing and presenting training using standard modules and training on special topics

-Ensures appropriate content of training modules

-Initiate operational change where required and communicate change in a positive manner.

-Considers a number of factors in planning, anticipate work and prioritize work to meet tight timelines.

-Direct others in prioritizing their work.

-Define systems or processes to consistently ensure the high standards required in Compliance.

-Effectively delivers messages to all audiences.

-Considers needs and level of audience in communication.

-Uses logical persuasion in discussions and presentations.

-Determines efficient and appropriate method of communication.

-Understands impact of decisions and actions on business and consults with appropriate colleagues and management as applicable

-Promotes and maintains productive working relationships.

-Mentors others in establishing good working relationships.

Requirements

-Must have an in depth knowledge of regulatory requirements for assigned territories.

-Is recognized as a knowledgeable resource within the department and from other departments on a range of topics and someone whose opinion is sought as a regulatory resource.

-Understands current global and regional trends in regulatory compliance.

-8+ years of relevant experience and a BS.

-6+ years of relevant experience and an MS.

-Relevant work experience consists of working in a pharmaceutical quality control, quality assurance or compliance environment.