A temporary QC Project Manager reporting to the Quality Control Director, responsible for managing the Quality Control start-up activities associated with a new state of the art Sterile Drug Product Manufacturing facility.

Key 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 under the remit of the Sterile Drug Product Facility Start Up.
• Compliance with all BMS Policies, Standard Operating Procedures and Registered Specifications.
• Ensure the new laboratory within the Global Biologics Laboratory Building is set up to meet the needs of the new Sterile Drug Product Facility
• Ensure the new GBL 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
• Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
• Review and Approval of project strategy reports, protocols and associated Project documentation.
• Participate in regulatory agency inspections as required.
• Strategically plan and implement procedures and systems to maximise operating efficiency through the use of Operational Excellence tools.
• Manage and contribute to the achievements of department productivity and quality goals.
• QC Point of contact at all SDP meetings, liaison with network SMEs such as Micro CoE, ASO and MS+T
• Build schedules and ensure delivery timelines are met
• Manage headcount and hiring schedule in line with agreed timeframe. Ensure new hires ready to support key activities and meet site timelines.
• Support Equipment Qualification timelines, URS generation, Attend FATs
• Ensure all equipment, lab design, methods are accounted for and can be introduced successfully into SDP site
• Troubleshooting issues and resolving problems

Qualifications & Experience

• Minimum of a BSc in Science or related discipline
• Minimum of 8 years hands on experience in a GMP Laboratory Setting
• 4 years Project Management / People Management experience
• Strong background in Quality and Aseptic Manufacturing is required
• Personal and Project management skills
• Experience leading cross-functional teams