Director, QC - Reference Material and Critical Reagents

EPM Scientific - King of Prussia, PA

Full-time - Senior

King of Prussia, PA

Administrative and Support Services

About the position

The Director of Reference Materials and Reagents is a senior leadership role within a global biopharmaceutical organization, responsible for ensuring the availability, maintenance, and regulatory compliance of critical reagents and analytical standards across the organization's portfolio. This position requires strategic oversight and collaboration with various departments, including R&D, Quality Control, and Regulatory, to manage the lifecycle of reference materials and maintain relationships with outsource partners.

Responsibilities

• Develop and implement strategies for the supply of reference materials and reagents.
• Lead a team overseeing the supply model.
• Ensure quality compliance with the organization's standards.
• Assess supply changes and determine regulatory needs.
• Maintain QMS for the team and partners.
• Manage self-inspection schedules.
• Provide support for root cause analysis and corrective actions.
• Serve as the primary contact for the organization's customer queries and audits regarding reference standard and critical reagents.
• Respond to regulatory and customer queries, and update regulatory dossiers.
• Support audits of outsource partners.
• Manage relationships with outsource service providers.
• Identify and implement improvements to the outsource model.

Requirements

• Over 10 years of experience working within Quality Control and Analytical Development.
• Experience with reference standard and critical reagents is a must.
• Strong leadership experience - 7 years minimum.
• Must have experience in a global, matrix organization.
• Must have experience in a strategic focus role including implementing and establishing systems, processes, procedures, programs, etc.
• Must have a continuous improvement mindset.