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Assessment Manager/Senior Manager, GVP Compliance

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.

SUMMARY DESCRIPTION:

This position is responsible for conducting independent evaluations of BioMarin’s pharmacovigilance (PV) system through internal and external QA audits to assess compliance with PV and REMS regulations and guidelines (e.g., FDA, EMA, MHRA, Asia Pacific and Latin America); corporate policies; and standard operating procedures (SOPs).  In addition, the position will be providing advice and counsel to internal Key Stakeholders on PV matters. 

Strong knowledge of global GVP regulations, and excellent communication and organizational skills are required.  In order for the candidate to be successful in this position, the candidate must possess dynamic interpersonal and teamwork skills.

RESPONSIBILITIES

·       Assure the integrity and quality of safety information by independently manage, lead, participate, and follow-up on domestic and international internal and external PV and REMS audits.  GVP audits include, but are not limited to: PV and REMS partners, vendors, affiliate offices and internal departments/systems.

·       Lead GVP Compliance audit activities by:

o   Identifying audit team members

o   Facilitating pre-audit meetings with internal departments

o   Preparing and conducting audits

o   Identifying audit observations and generating audit reports

o   Communicating audit results and observations to auditee and internal management

o   Assisting or guiding auditees in the development and completion of corrective and preventive action (CAPA) plans

·       Act as a subject matter expert by providing GVP Compliance advice to internal Key Stakeholders, including updates for applicable regulations and guidelines.

·       Provide updates and quality reviews of PV and REMS documents, including SOPs, PSMF, and REMS material. 

·       Core Membership of the Regulatory Inspection Support Team.  Provide inspection readiness and on-site support for regulatory inspections, and assist with the development and review of CAPA responses. 

·       Communicate critical information regarding significant quality or patient safety risk to Senior Management and Key Stakeholder.

·       Participate in the development and/or enhancement of corporate GVP/GxP Compliance processes, procedures and best practices.

·       This position will require domestic and international travel around 30% of the time.

EDUCATION

BA/BS in life sciences, health sciences, or other technical area.

EXPERIENCE

Minimum 5 years’ experience in the Pharmaceutical, Biotechnology or Medical Device industry; in PV Quality Assurance/Regulatory Compliance or equivalent.

  • Current knowledge of global PV/REMS regulations and guidelines – US Code of Federal Regulations, EMA, MHRA, ANVISA and ICH Guidelines.
  • Experience in domestic and international compliance and auditing.
  • Must be detail oriented, with excellent oral and written communication skills.  Also, must be able to partner with a diverse group of staff/international consultants with different strengths and skills and have the ability to prioritize work, manage multiple projects, while maintaining quality.
  • Ability to work independently and as part of a team in a very busy work environment.
  • Experience in developing, writing and implementing SOPs

·       Auditor certification is a plus.

WORK ENVIRONMENT / PHYSICAL DEMANDS

Office environment consistent with desk work and traveling activities.

EQUIPMENT

Access to corporate computer network

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.

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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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