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Summary
This role is accountable for quality oversight of facility commissioning, qualification and validation activities at the Marlborough manufacturing plant. This is an exciting opportunity to oversee the start-up of a new manufacturing facility as well as build a team and culture from the ground up.
Client Details
Our client is a disruptive Life Sciences provider focused on advancing the science of biopharmaceutical manufacturing and development.
Description
- Hire and lead a high-performing Technical Quality team responsible for the site risk-based qualification and validation program
- Provide quality oversight of facility commissioning and qualification activities, to include equipment, utilities, instruments, and materials management
- Implement global quality systems, procedures, and master plans at the site to support validated facility and equipment status throughout their lifecycle
- Establish and facilitate a robust and efficient site change control and material review boards
- Provide site oversight of method and process validation in alignment with global quality functions
- Develop and deploy site data integrity program, in alignment with global Digital Quality
- Provide Technical Quality support for internal and external teams and projects
- Manage budget for department and project resources
Profile
- Bachelor's degree or higher in Life Sciences, Chemistry, Biology, Engineering or related field
- Minimum of 10 years of pharmaceutical or biotechnology industry experience, with minimum of 5 years in a quality oversight function
- Previous managerial experience
- Hands-on experience with oversight of GMP operations at a biologics or gene therapy facility
- Comprehensive knowledge of global GMP regulatory requirements for qualification and validation
Job Offer
- Very competitive base salary and benefit package with opportunity for stock options
- Opportunity for career growth and development
- Join a highly disruptive and innovative biopharmaceutical provider