Director, Head of Global Supplier QualityLocation Cork, Ireland Workstyle Open to Hybrid Apply
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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.
The Director, Head of Global Supplier Quality reports to the Senior Director, Global Quality Assurance, and is accountable for overseeing, maintaining, and improving all Global Supplier Quality processes and infrastructure. This role is accountable for the management of Quality Agreements, Supplier Changes, and Deviations where applicable.The role will direct the activities within the Supplier Quality function, and with cross functional teams to prevent defects, and continuously improve supplier performance within BioMarin sites and the external supply network. The Director, Head of Global Supplier Quality will collaborate with Procurement and Suppliers to conduct quality improvement activities within Supplier processes to improve compliance and prevent non-conformances from reaching BioMarin sites or impacting the external supply network.
- Responsible for strategic planning and management of global supplier quality activities. Will lead the Supplier Quality team to effectively execute daily activities in partnership with global procurement, manufacturing, and all other relevant stakeholders across functional groups.
- Manage quality related to external suppliers with a focus on materials related to Technical Operations.
- Collaborate with Manufacturing Sciences and Technology, Global Sourcing and Procurement, and Process Sciences to identify what attributes render materials, suitable for use in our processes. Own and approve documentation used as the basis for sourcing.
- Ensure that our internal processes are fit for purpose, maintain compliance, and inspection readiness. By extension, and with equal emphasis and rigor, collaborate effectively with our externalsuppliers to ensure that their processes are comparably fit for purpose and inspection ready.
- Develop, define, and apply risk-based oversight approaches as part of the BioMarin Global Quality Management system. Establish and manage against key process indicators
- Leverage and integrate technology to aggregate data on attributes and performance; use pooled data to distinguish signal from noise and gain actionable insights.
- Develop appropriate quality systems, skills and organizational structure to meet quality expectations and business needs.
- Develop and monitor budgets for the Global Supplier Quality function, including ensuring appropriate resources to meet/exceed quality goals and TOPs objectives.
- Recruit, coach, develop, and lead a highly effective and motivated Supplier Quality group across multiple geographical locations while mentoring and coaching the team in leading best practices in supplier quality and ensure their ongoing career development.
- Perform periodic talent reviews and ensure succession plans are in place for key leadership and technical roles.
- There is a critical importance of ability to lead and navigate in a matrix and global organization with a broad scope and high level of complexity.
- Initiate and enhance training programs to advance understanding of regulatory requirements, supplier quality improvement programs and problem-solving techniques.
- Leverage talent and experience across BioMarin and drive a standardized approach to Supplier Quality across the global network.
- Bachelor’s degree in Life Sciences, Engineering, or other related discipline is required
- Masters in Business Administration desirable but not required
- Six Sigma Black Belt desirable
- Minimum 15 years of quality assurance, quality control, manufacturing, combination product / medical device production, or other relevant experience.
- At least 10 years GxP compliant Biopharma operations experience required. In-depth knowledge Quality standards (GMP, GCP, ISO 9000, ISO13485, etc.) and experience with medical devices or combination products (knowledge of CFR 21 Part 820).
- Experience with kaizen, human error prevention / human factors engineering, project management, knowledge management / design history file, ERP (Oracle) systems, and new product launches desirable.
- Experience representing processes and related data in regards to inspections/audits by the FDA or other regulatory bodies.
- Demonstrated ability to partner with other functional groups to achieve business objectives required
- Leadership ability to develop and implement organization and functional strategy. Initiates, sponsors and implements change and a demonstrated track record in QA Improvement.
- Works with a sense of urgency and attention to detail at all times.
- Experience successfully leading transformational change, acting as a change agent or change sponsor
- Superior communication skills – Oral, written and formal presentation skills with diverse audiences including senior management, middle management and line staff
- Creative problem solving skills
- Comfortable and effective working indirectly through others
This is a hybrid workstyle, requiring a minimum of 2 days onsite in Shanbally
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.