A global biopharmaceutical organization is hiring for a global leadership role that works cross functionally with R&D, Quality Control, and Regulatory. If you're an innovative leader that's looking for a strategic focused position that impacts an organization globally, then please apply in!
Job Title: Director of Reference Materials and Reagents
Overview: Responsible for the availability maintenance, and regulatory compliance of critical reagents and analytical standards across the organization's entire portfolio globally. This individual will be managing the long-term supply and lifecycle of reference materials and critical reagents products, and maintain relationships with outsource partners to ensure timely and secure supply.
Key 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.
Key Qualifications:
- 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.
