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GxP Compliance Specialist (TEMPORARY)

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.

Duties


Under the supervision of management, this temporary position is responsible for the support of our cGxP regulatory compliance programs. Responsibilities include but are not limited to designing, developing and implementing programs to assure compliance with corporate policies and regulatory agencies. The scope of the responsibilities include management of compliance metrics, completing assigned projects to enhance compliance, use of specific IT systems in generating reports, and supporting health authority inspections.

Skills



    • Past experience working for Pharmaceuticals is desirable

    • Past experience in Quality and/or Compliance is desirable

    • Experience or participation in project management

    • Experience with using and running reports from database systems

    • Demonstrated interpersonal (critical thinking, desire to learn), planning, problem solving, and organization skills.

    • Demonstrated communication skills, both written and orally, across different geographies and cultural backgrounds.

    • Experience in use of Quality Tools such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact based decisions making is desirable.

Education



  • Bachelor Degree in biotechnology, engineering, law, natural sciences, pharmaceuticals or human healthcare


We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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