Position Summary
Crusierath Biologics is seeking a Senior Manager of Quality Control to Project Manage the Quality Control start-up activities in support of the transition of storage and testing of Drug Product Stability from the BMS Devens facility to Cruiserath. This position will provide Strategic Guidance & Oversight, technical and compliance support as a QC Leader to support QC Operations at BMS Cruiserath. Reporting to the Quality Control Director, this position has responsibility for developing the Project Strategy, Defining the Project Schedule, managing Schedule adherence, QC Hiring strategy, QC Laboratory Facility / operational Design, QC Stability Governance across Technical Transfer, Operational Readiness and Capital Expense. This position is responsible for the overall QC readiness for the new Drug Product Stability Storage and Testing. This is a 12 month fixed term contract.
Key Responsibilities
* Overall accountability for timely delivery of the QC operational readiness requirements for testing switch-on in 2026
* Overall accountability for timely delivery of the QC requirements for on-site storage readiness in 2027
* Responsible for the Drug Product Stability Storage facility design and GMP certification
* Overall responsibility for identifying, defining, scheduling, coordinating and driving to completion all Quality Control activities within the remit of the Drug Product Stability readiness operations.
* Work with the Site Projects team to ensure the delivery of Storage for Long term, Stressed and Accelerated Stability
* Work with the QC Projects team & the Global Stability Team to ensure the delivery of Method Transfer activities under the remit of Drug Product Stability.
* Principal Quality Control Liaison with each of the main Stability workstreams (Technical Transfer, Operational Readiness and Capital Expense)
* Responsible for the development of the QC Stability Hiring Plan with accountability to adhere to the phased hiring schedule
* Compliance with all BMS Policies, Standard Operating Procedures and Registered Specifications.
* Ensure the QC Organisation is set up to meet the needs of the new Drug Product Stability Program at Cruiserath
* Ensure the new Stability Storage Facility is set up 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 Global Stability and Site Project teams through strong communication and focus on key priority milestones
* Keeps abreast of current corporate and industry requirements and compliance trends as they pertain to laboratory operations and Stability Testing
* 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 Drug Product Stability meetings, liaison with network SMEs such as Method Lifecycle Microbiology Centre of Excellence, Analytical Science Organisation and Manufacturing Science & Technology
* Responsible for building the QC detailed 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 any Equipment Qualification timelines required
* Ensure all equipment, lab design, methods are accounted for and can be introduced successfully into the current LOC Laboratories
* Troubleshooting issues and resolving problems in a timely manner
* Inspires transformative thinking and motivates employees to deliver benchmark performance.
* Leads and fosters an environment of continuous improvement.
Qualifications & Experience
* The successful candidate must possess a Bachelor/Masters in Science or Science related discipline. A minimum of 10 years' experience in the Pharmaceutical Industry.
* Deep and demonstrated understanding and experience of the principles of GMP / GDP
* An accomplished team leader of project teams with the ability to motivate and develop QC teams through effective feedback and coaching
* The candidate will have proven success working well in a team environment, as well as proven leadership skills to manage a project in a dynamic environment.
* Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture
* Experience with technical transfer of new products is essential, as well as experience interacting with regulatory agencies.
* Experience with a stability testing program is desirable
* Must be experienced in managing large complex projects.
* Experience in building and designing laboratories is desired
* Extensive knowledge of US and EMA GMP regulations and guidance.
* Demonstrated leadership, interpersonal, communication, and motivation skills.
* Demonstrated understanding of test methods and instrumentation associated with the testing of biopharmaceutical processes including microbiological, chemical & functional testing
* Planning and organizing skills are required to plan, execute and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment.
Why you should apply
* You will help patients in their fight against serious diseases
* You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
* You'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
EEO Statement
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.
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