Associate Director, Global Supplier Quality

Location:  Cork, Ireland Category: Quality

Description

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.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

This position reports to the Head of Global Supplier Quality and will support and maintain quality oversight for one or more of the following processes: Raw Material Supplier Changes, Supplier Investigations, Approved Supplier List (ASL) and associated Purchasing Controls, Quality Agreements for Raw Material Suppliers, and Raw Material Specification oversight.  There will be specific focus on building and maintaining Supplier relationships and leading improvements to Supplier oversight.

RESPONSIBILITIES 

  • Establish and influence global alignment on supplier related policies and procedures
  • Implement, improve, and oversee risk-based and inspection-ready supplier quality processes, ensuring alignment with regional, global, and industry expectations
  • Work cross-functionally with leaders inside and outside of technical operations to align strategies and define actions needed to continuously improve the health of supplier quality processes
  • Provide technical expertise and oversight to resolution of issues related to material suppliers
  • Provide quality oversight and approval of supplier-related documentation
  • Monitor performance of applicable quality management system records to ensure timely completion of activities, implementing activities needed to improve performance as needed
  • Establish and maintain relationships with suppliers, proactively initiating and supporting continuous improvement initiatives
  • Report quality system and supplier performance metrics to relevant governance meetings
  • Actively lead and/or participate in teams supporting the global external quality organization, representing the supplier quality function and upholding supplier quality standards
  • Participate in inspection readiness activities and represent the supplier quality function and documentation in regulatory inspections and audits
  • Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin and for Supplier related approaches utilized at BioMarin
  • Support CMC regulatory filings for all BioMarin products
  • Up to 25% travel required

EXPERIENCE

Required Skills:

  • 10+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems
  • 4+ years experience in a leadership position, with direct experience overseeing supplier quality activities preferred
  • Demonstrated proficiency in leading cross-functional improvement projects
  • Excellent organizational and management skills, with ability to effectively plan, schedule, execute, and track complex cross-functional projects
  • Ability to speak, present data, and defend approaches in front of executive leadership and regulatory inspectors
  • Ability to comprehend technical information related to raw materials and regulatory expectations

Desired Skills:

  • Experience with oversight of supplier, service provider and/or raw material processes strongly preferred
  • Experience with TrackWise and/or Veeva quality systems
  • Experience leading and participating in international project teams
  • Experience in presenting or defending departmental activities in regulatory inspections and/or audits


EDUCATION

  • BA or BS in a technical discipline (physical or biological sciences). Equivalent experience may be considered.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated.


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