Job Opportunity:
We are seeking a seasoned Quality Control Manager to oversee the support operations of our Quality Control team.
This role will involve providing strategic direction to staff, ensuring equipment qualification and maintenance programs align with regulatory requirements, and collaborating with partner groups to establish internal standards for equipment.
* Maintaining oversight of QC equipment lifecycle activities (procurement, installation, qualification, maintenance, and decommissioning)
* Providing strategic guidance to Managers and staff supporting the equipment
* Ensuring equipment qualification and maintenance programs are aligned with regulatory agencies' requirements
* Collaborating with QC partner groups to establish internal standards for equipment
* Leading QC equipment validation/qualification efforts through partnering and interaction with QA Validation and IT groups
* Managing oversight of preventive and corrective maintenance monitoring program
* Managing oversight of QC external laboratories activities and performance monitoring of external testing laboratories
* Supervising the issuance and approval of Quality agreements and SLAs with contract labs
* Verifying site Manufacturing licence and global procedures reflect current contract lab utilization
* Identifying and calling out issues at contract laboratories to QC leadership
* Sourcing, coordinating, and project managing GMP activities relating to new contract lab introduction
* Travel may be required in support of external contract laboratory testing activities
* Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations
* Responsibility for equipment automation and associated projects