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Senior Program Manager, Clinical Supplier Quality

  • Job type: Permanent
  • Location: Boston, Massachusetts
  • Salary: Negotiable
  • Job reference: 179671/001_1541191571
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 02/11/2018

Senior Program Manager, Clinical Supplier Quality

Greater Boston Area

A Top-10 pharmaceutical leader that focuses on developing and manufacturing world-class innovative medicines in Neuroscience, Oncology, and GI are currently seeking a Senior Program Manager, Clinical Supplier Quality as their company is rapidly expanding! This company has received recognition for their overall success and is looking to increase headcount within the Quality Department. Now is a pivotal time to get in with this group as you will have the ability to lead and impact their robust pipeline of promising new medicines.

The Senior Program Manager, Clinical Supplier Quality will have the following responsibilities:

  • Ensure external suppliers meet quality standards.

  • Ensures clinical, bioanalytical, pharmacovigilance, and R&D marketed product supplier audits are conducted in accordance with company requirements.

  • Develop and maintain a global supplier management plan, utilizing a risk-based approach to selecting suppliers for audit. Partner with Supplier Quality Program Manager to ensure audits are performed and reported in accordance to plans.

  • Analyze supplier audit program results, quality issues, and investigations in order to optimize global operations and overall global state of compliance. Identify key compliance risks and develop mitigation strategies.

  • Assist in the coordination of Quality Management Working Group Meetings with key vendors, as applicable.

  • Manage individual consultant auditors to ensure that all audits, resultant reports and other work product are of acceptable quality and in compliance with company requirements.

  • Provide management to the global consultant auditors to identify, select and train new consultant auditors and provide management to the overall strategy for consultant auditor re-assessment.

  • Develop supplier key performance indicators. Monitor performance/compliance issues identified across vendors.

  • Ensure reports and corrective actions are developed and completed within timelines mandated in internal procedures related to clinical, PV, and bioanalytical suppliers. Provide appropriate risk analysis for key stakeholders to make critical decisions.

The ideal candidate will have:

  • B.S. in Science, Nursing, or related scientific field.

  • 7 years of applicable pharmaceutical drug development/clinical/pharmacovigilance experience with at least 4 years of GCP or GVP related Quality Assurance experience.

  • Minimum 4 years of quality assurance auditing experience

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