Senior Director of Biostatistics at Orchard Therapeutics leading statistical innovation for clinical drug development. Overseeing a high - performing Biostatistics team and collaborating with regulatory agencies.
BI
Hybrid Director, Global Supplier Quality Management
Posted 5 days ago
About the role
- Director of Global Supplier Quality Management at BioMarin focusing on successful supplier quality oversight and improvement. Leading digital advancements in supplier management while ensuring compliance and regulatory adherence.
Responsibilities
- Establish and maintain a risk-based, fit-for-purpose Global Supplier Quality Management framework.
- Define and execute the global Supplier Quality strategy to ensure consistent oversight, compliance, inspection readiness, and continuous improvement.
- Own and oversee Supplier Quality core processes, including supplier qualification and lifecycle management, quality agreements, supplier changes, deviations, CAPA, and supplier auditing activities.
- Ensure quality oversight of external suppliers, focusing on raw material specification management.
- Develop key Supplier Quality performance indicators, ensuring trending, signal detection, and timely actions.
- Collaborate with Procurement and Suppliers to drive quality improvement initiatives and enhance supplier capability.
- Lead supplier quality issue investigations, risk assessments, and mitigation strategies.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related discipline required.
- Minimum of 15 years of experience in Quality Assurance, Supplier Quality, Manufacturing, or related roles within a highly regulated industry.
- In-depth knowledge of global quality and regulatory requirements (e.g., GMP, GCP, GDP, ISO standards, 21 CFR).
- Demonstrated experience leading global supplier quality programs and managing complex external supply networks.
- Proven leadership experience with the ability to develop, mentor, and inspire high-performing teams.
- Strong experience operating in a matrix, global environment and influencing without direct authority.
- Experience leading or sponsoring transformational change, including digital transformation initiatives.
- Demonstrated experience using data, analytics, and digital tools to improve quality outcomes; experience with AI-enabled solutions a strong plus.
- Excellent communication, collaboration, and stakeholder management skills, including interaction with senior leadership and regulators.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
Job title
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Not specified
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