Client is looking for a very senior level Validation Director for a 3 year assignment, several director level prior roles, pharma/biologics validation specifically, leading validation projects and teams.
- The project is a Cell and Gene Therapy greenfield site with two buildings. We will construct a Central Utilities Building and a manufacturing facility. The first phase will focus on producing a drug substance with an expectation to begin drug product manufacturing in the dosage form of a medical device. The current design includes 50-60 single use bioreactors of all sizes. New technologies are being considered. The complexity of the project and inherent risks cannot be understated and only the most experienced candidates will be considered.
- The candidate will represent as our C&Q signatory and report directly to the Project Manager. The candidate will be supported by Regional Lead for matters of Policy and Procedures.
- The candidate will have direct reports that will not work for the same supplier.
- The candidate must have the following:
- Have the requisite skill set for C&Q/Validation Directors in the industry
- Have led C&Q on multiple large projects with references provided
- Have led direct reports
- Commitment to be on site >80%
The key responsibilities of the Validation Director will include:
- Selection of resources in support of C&Q document preparation and execution.
- Manage C&Q resources including safety.
- Managing the C&Q Budget.
- Manage the C&Q execution schedule.
- Author C&Q progress reports and slides as requested by the Project Manager
- Enforcing Clients C&Q policies and procedures including paperless validation software configuration.
- Serve as the project’s Kneat Power User and Admin.
- Author and maintain the C&Q Plan.
- Facilitate Equipment and Design Risk Assessments.
- Facilitate approval of all equipment User Requirement Specifications.
- Lead Design Qualification.
- Facilitate C&Q Protocol development.
- Attend Factory Acceptance Testing.
- Coordinate C&Q execution with all stakeholders.
- Facilitate System Acceptance and Handover.
NH: Validation Director (233770)