Interim Director QA Operations

Apotech Consulting is looking for an Interim Director- QA Operations (Fluency in French Required) on behalf of our Pharmaceutical/Biotech client.  

This is a contract position – 4 months.  Onsite as needed. 

Title:  Interim Director QA Operations (Fluency in French Required)

Role:

Our client, an emerging biotech company with an innovative technology platform is converting a pilot scale facility into a commercial GMP manufacturing operations for COVID 19 vaccine production. The Interim Director of QA Operations will work in two capacities, as a leader of the QA group overseeing the planning and execution of all CMC QA activities as well as in an individual contributor capacity. The successful applicant will need to operate in a high-level management role directing, reviewing and coaching as an individual contributor reviewing or creating various QA documents.

The quality management systems in scope include qualification of equipment and utilities, process validation, calibration, maintenance, batch record review and change control.   In this role, the successful applicant will review and sign off on controlled documents such as SOPs, master batch records and validation protocols

Experience:

• 10+ years of QA experience supporting CMC activities from development through GMP manufacturing.
• Experience with QA support for plant start-up a plus.
• Strong knowledge of quality management systems typically encountered in commercial GMP operations such as validation, qualification, change control, batch record review, calibration and maintenance. 

Education:

• Bachelor’s degree in science or engineering.
• Fluent in French and English