Description:
Headcount Solutions is sourcing a QC Project Manager for our multinational client’s biologics site in Dublin. Reporting to the Quality Control Director, this person will be responsible for managing the Quality Control start-up activities associated with a new state of the art Sterile Drug Product Manufacturing facility.
Main Responsibilities:
- Overall responsibility for identifying, defining, scheduling, coordinating and driving to completion all Quality Control Projects within the remit of the Sterile Drug Product facility start-up operations.
- Work with the QC Projects team to ensure the delivery of Method Transfer activities.
- Ensure the new laboratory is set up to meet the needs of the new Sterile Drug Product Facility
- Ensure the new laboratory is set in a safe manner with safety as a primary concern in its design.
- Work closely with each of the QC teams to ensure they are informed of critical milestones, progress and support requirements.
- Provide an effective and efficient QC Service to the Sterile Drug Product Project team through strong communication and focus of key priority milestones.
- Review and Approval of project strategy reports, protocols and associated project documentation.
- Participate in regulatory agency inspections as required.
- QC Point of contact at all Sterile Drug Product Facility meetings, liaison with network SMEs such as Micro CoE, ASO and MS+T.
- Build schedules and ensure delivery timelines are met.
- Support Equipment Qualification timelines, URS generation, attend FATs.
- Ensure all equipment, lab design, methods are accounted for and can be introduced successfully into the site.
Qualifications & Experience:
- BSc in Science or related discipline.
- Minimum of 8 years hands-on experience in a GMP Laboratory setting.
- Strong background in Quality and Aseptic Manufacturing is required.
- Experience leading cross-functional teams.
- Knowledge of applicable regulatory requirements is desirable.