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Associate Manager, Regulatory Compliance, Req#1470
Gilead, Inc.
Foster City, CA
Gilead Sciences is a
biopharmaceutical company that discovers, develops and commercializes
innovative therapeutics in areas of unmet medical need. Our mission is
to advance the care of patients suffering from life-threatening diseases
worldwide. Headquartered in Foster City, CA, Gilead has operations in
the United States, Europe and Australia. We currently have an excellent
opportunity for a proactive individual with the ability to conduct
process audits and external GLP facility audits, routine study audits,
regulatory training, and SOP review/authoring.
Essential Duties and Job Function:
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Responsible for maintaining current knowledge of Compliance program and
of applicable company standard operating procedures for areas of
responsibility |
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Ensures
assigned departments within the company site (e.g. Durham, Foster City,
Seattle, Westminster) are aware of compliance requirements and
responsibilities |
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May
direct others in accomplishing Corporate and departmental objectives |
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Responsible for maintaining current knowledge of applicable regulatory
requirements through attendance at industry sponsored meetings and
seminars, and in-house training |
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Responsible for providing guidance on interpretation and application of
specified regulations |
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Follows-up on questions from assigned departments |
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May
assist in implementation of standard operating procedures and systems
needed to comply with regulatory requirements |
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Ensures
completion of assigned audits |
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May
lead specific types of audits including internal process audits,
external vendor audits, or document reviews. |
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Implement procedures and audit tools for the conduct of internal and
external audits. |
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May
coordinate audit follow-up and corrective action planning with
functional area management. |
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Provides support during regulatory agency inspections. |
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Work is
performed under minimal direction of a senior Compliance professional. |
Knowledge, Experience and Skills:
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Typically requires a BS degree in a scientific discipline with
minimum 7 years of relevant experience in the pharmaceutical quality
control, quality assurance or compliance environment, or a MS degree
in a scientific or health with minimum of 5 years of relevant
experience in the pharmaceutical quality control, quality assurance
or compliance environment. |
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Excellent organization skills and ability to work on multiple
projects with tight timelines is required. |
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Must have an excellent attention to detail and ability to
consistently meet high standards required in Compliance. |
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Excellent verbal, written, and interpersonal communication skills
are required. |
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Must have a full working knowledge of regulatory requirements,
including FDA and OECD GLPs |
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Is
recognized as a knowledgeable resource within the department on a
range of topics and someone whose opinion is sought as a regulatory
resource. |
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The
candidate must possess strong negotiation skills and the desire to
maintain a current knowledge base in order to influence the
regulatory environment throughout the company. |
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The
candidate must be able to effectively work in teams and lead
specific projects through to completion. |
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The
candidate must be able to analyze audit data utilizing company
databases. |
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The
candidate must be able to identify areas for improvement and
recommend possible solutions and/or implement appropriate changes as
required. |
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Experience in implementing electronic tracking systems (e.g. audit
tracking, CAPA) is a plus. |
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The
candidate must be flexible in a working environment subject to
growth and changing priorities. |
Some
travel is required.
Reference Req# 1470 and apply online today:
www.gilead.com/careers
We are an Equal Opportunity Employer
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