Director, Quality Assurance (Bioservices)

10-12 years’ experience working in a Quality driven life science, regulated environment with hands-on experience on supporting medical device pre- and post-market activities.

Experience interpreting and complying CLIA, CAP, GLP, GLCP, FDA QSR, ISO15189, ISO 13485, ICH

Experience auditing and interacting and relationship building with the public (regulators, vendors and clients)

Reasonable estimate of the current range

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This Director of Quality Assurance (Bioservices) role is responsible for implementing and maintaining the quality systems including organizational resource planning, implementation of technology, and developing and implementing tactical plans to meet Company objectives.

This position is also responsible for supporting the product quality strategy for Precision for Medicines regulated diagnostic and companion diagnostic product portfolio.

Plan and direct resources and activities of the quality and compliance functions across all facilities globally

Provide oversight to site specific quality leadership team

Identify/lead and participate in process improvement initiatives and continue the alignment of the global quality systems across the sites

Provide updates to the company leadership regarding status of the quality system, compliance status and performance relating to quality