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Director, GxP Compliance (Americas and Asia Pacific)

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.

Director GxP Compliance for The Americas and Asia-Pacific

High Level Description

This position is located at BioMarin’s San Rafael Headquarters and will act as the Compliance group lead for the Americas and Asia-Pacific regions.  This individual will lead the distribution compliance function for BioMarin’s global clinical and commercial products to ensure compliance with Good Distribution Practices (GDPs).  In addition, this person will support regulatory authority GxP inspections for BioMarin internal operations, regional offices, and those contracted at third parties.  This includes management of global responses, subsequent tracking and verification activities.  Other responsibilities entail management of compliance metrics; regulatory intelligence; marketing application reviews and assigned projects to enhance compliance.

The GxP Operations (Americas/APAC) team leader is responsible for managing all aspects of distribution and specified inspections across the Americas and Asia Pacific, which include:

Operational Accountability

Distribution Compliance

  • Work closely with multiple stakeholders to ensure maintenance of a supply chain compliance
  • Lead review of investigations for issues; associated root causes and corrective actions to prevent future occurrences
  • Manage the Distribution Compliance Management Review program and active management of associated metrics in cooperation with EUMEA regional Distribution Compliance lead
  • Support the distributor or business partner selection and monitoring process through collection and evaluation of GxP compliance history in cooperation with the Compliance Audit function
  • Support the generation and update of Distribution Quality Agreements for distribution and third- party logistics contractors
  • Provide on-site support at regional offices, or distribution sites as necessary
  • Responsible for product returns and recall programs

Regulatory Inspection Support

  • Support constant inspection readiness by timely executing required program activities throughout the clinical and commercial product life-cycle
  • Collaborate with key stakeholders to ensure inspection readiness and proper coordination during the course of inspections
  • Represent function during regulatory inspections and provide on-site inspection management during inspections as necessary
  • Manage inspection responses to include global evaluation; execution; and effectiveness checks
  • Owner of inspection tracking and inspection management software and business processes
  • Identify and track inspection “near misses”; identify and track corrective actions as part of predictive compliance
  • Engage proactively with stakeholders to build a progressive and integrated GxP Compliance function
  • Provide GxP Compliance and Inspection Management training in order to maintain a high level quality culture
  • Support the emerging regulations and proactive compliance programs
  • Monitor developments in GxP compliance and create actionable compliance intelligence with follow-on projects targeting predictive compliance
  • All staff are required to follow defined processes and policies; behave in a professional manner with integrity and strive for right first-time performance
  • Up to 20% travel
  • Other duties as assigned

Leadership

  • Represent Compliance with project teams, other departments, and committees as needed
  • Develop staff to realize their full potential and achieve peak performance for the group
  • Drive continuous compliance improvement for the organization across organization boundaries and formal lines of reporting
  • Work with senior leaders to proactively identify, communicate/escalate and mitigate material compliance risk
  • Ensure staff are assigned appropriate curricula and have a combination of training, education and experience to execute assigned responsibilities

Experience:

  • 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
  • 7+ years of prior supervisory/management experience
  • Excellent interpersonal and communications skill
  • Results oriented; effectively manages a multitude of projects efficiently
  • Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker
  • Builds strong, effective working teams; builds relationships to share best practices, and solve shared problems
  • Demonstrates in-depth understanding and application of cGxP principles, concepts, practices and standards
  • Lean and/or Six Sigma certification from a recognized certifying body or global organization engaged in Lean Six Sigma
  • Prior experience in Quality Assurance, Compliance function, Regulatory Affairs, or GxP project management

Education:

  • BA/BS or Advanced Degree in Business, Engineering, Law, Science or Technology



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