Skip Navigation

Director GMP Compliance, Product Compliance Lead

Location Cork, Ireland

Director GMP Compliance,Product Compliance Lead (PCL)

High Level Description

This position will be located at BioMarin’sSan Rafael, CAHeadquarters and will report to the Executive Director, GxP Compliance.  You will serve as a key member of the GxP Compliance extended leadership team; and be responsible for compliance oversight of BioMarin’s GMP activities for commercial and clinical products.You willprovide advice and guidance to cross-functional teams in order to support the TOPS organization in their achievement of product milestones while maintaining an appropriate level of compliance.

The PCL is a core member of the CMC team and the single point of contact for the product.

This position requires a broad range of knowledge and experience in GMP Compliance for biologic and chemical processes, analytical methods, contract manufacturing and testing, and understanding of the international regulatory landscape.

Operational Accountability

Leadership

  • Attend and participate fully in CMC team meetings, and other relevant forums, to provide compliance expertise to influence global strategies
  • Provide compliance expertise and strategic leadership for clinical and commercial programs by partnering with Technical Operations and other stakeholders
  • Partner with CMC team(s) and the compliance organization to identify compliance deliverables for the program(s)
  • Lead Compliance Partner Team(s) (CPT) to define, monitor, and identify actions to enable a program-appropriate level of compliance and manage compliance deliverables in support of the CMC team(s)
  • Coordinate communications and report on compliance programs, such as audit and contractor nominations, associated with each program
  • Facilitate inspection readiness across the program portfolio of manufacturers and labs as they graduate towards commercial approval
  • Liaise with product leads from GCP, GVP, and GLP Compliance organizations to maintain a comprehensive view of the program’s compliance status
  • Actively represent the Compliance organization on multiple GMP/TOPSforums
  • Work with internal and client group leaders to proactively identify, communicate/escalate and mitigate material compliance risk
  • Drive continuous compliance improvement for the organization across organizational boundaries and formal lines of reporting
  • Influence decision makers and utilize sound problem-solving skills to recommend options for implementation of compliant and effective solutions
  • Interface with stakeholders in a consultative fashion to influence compliance in operations
  • Represent Compliance during issue management and escalation scenarios
  • Actively participate in designing and effecting the GMP Compliance strategy
  • Aid in developing Compliance staff to realize their full potential and achieve peak performance
  • Inform stakeholders regarding compliance trends and changes

Global Compliance Program

  • Participate in the Compliance Update forum for TOPs executives
  • Contribute to the quarterly Board of Director Compliance updates; ensure report and presentation are to a high standard
  • Establish and report effective, risk based KPIs to help identify, communicate and manage key compliance trends and issuesby program
  • Engage proactively with stakeholders
  • Maintain expert level knowledge of compliance requirements and industry trends
  • Follow defined processes and policies; behave in a professional manner with integrity and strive for right first-time performance
  • Provide communications plan utilizing reports, presentations and internal communications
  • Up to 15% travel
  • Other duties as assigned

Experience:

  • 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
  • 5+ years of prior management level experience
  • Excellent interpersonal and communications skill
  • Ability to influence diverse stakeholder and drive accountability and decision-making cross-functionally
  • Demonstrated ability to partner with other functional groups to achieve business objectives
  • Results oriented; effectively manages multiple 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 toshare best practices, and collaboratively solve problems
  • Demonstrates in-depth understanding and application of cGMP principles, concepts, practices and standards
  • Prior experience with a combination of Quality Assurance/Control, Compliance, Regulatory Affairsand/or GxP project management

Education:

  • BA/BS in life sciences or related field
  • Advanced degree desirable, but not required
  • Six Sigma or other quality tools training desired
  • Other continuing education initiatives or relevant industry or compliance certifications

About our location

Cork

View

Hiring Insights

View
We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
Return to the top of the page