We've been retained for a critical leader that will serve as the Quality Site(s) Head (Senior Director), reporting to the Chief Quality Officer. This person that will oversee multiple commercial aseptic DP facilities supporting numerous products supplied across the world. This campus has fully integrated inspection, labeling, device assembly and packaging capabilities and is continuing to grow and expand the number of FF lines through significant capital investments.

This person will:

Oversee all aspects of Quality in a cGMP environment, leading a high performing team of >200

Be a member of the SLT (Site Leadership Team)

Interface directly with the FDA, EMA, PMDA, CFDA, ANVISA, etc.

Have a track record of growth and progression leading QA Ops or as a former Quality Site Head (operational experience at a site/plant is required)

Prior experience in aseptic DP is a must

This opportunity will have significant visibility across the organization and externally with partners and regulatory authorities in a faced paced, customer oriented environment.

Requirments:

Sterile Processing

Quality Control

Biologics

Aseptic Technique

Aseptic Processing

Combination Products

Quality Assurance

Good Manufacturing Practice (GMP)

This role is on-site based in Ohio. Relocation support is provided. Please apply if interested and we will follow up with additional detailed information.

RonanVance Clinical & Scientific Search

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RonanVance Clinical & Scientific Search | Quality Site Head