The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.
CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
The Center for Breakthrough Medicines seeks an intrinsically motivated quality professional with a growth mindset who will meet and exceed deadlines and quality expectations.
The Supply Chain Quality Assurance Specialist/Senior Specialist will be accountable to provide quality oversight on compliance and Good Manufacturing Practice (GMP) that pertains to the end-to-end Supply Chain activities to meet CBM’s standards and regulatory expectations. These include quality support of materials management including receipt, storage, release, distribution, logistics, supplier complaints and internal investigations.
The role will provide timely decisions and consultations in alignment with cGMP, CBM and regulatory guidelines.
- QA support to the CBM Supply Chain end-to end materials management program, including processing of supplier complaints, material receipt and release, inventory control, shipping, and distribution.
- Create material inspection plans in CBM's internal inventory management system.
- Escalate to Quality Management any quality and business risk(s) to CBM posed by materials suppliers.
- Monitor and communicate supplier performance.
- Manage supplier changes and impact evaluation to CBM.
- Conduct, execute and document thorough investigations and CAPAs. Ensure timeliness of deliverables through proactive intervention. May own CAPA action items or deliverables.
- Troubleshoot quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to a wide range of root causes
- Supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, and actions.
- Maintain metrics
- Support management reviews and other presentations
- Maintain knowledge of regulatory environments, cGMPs, FDA policies and current industry trends.
- Engage in cross functional organization to develop policies and processes to comply with new cGMP, USP, and CFR requirements/guidance at the site
- Implement safety, quality and compliance improvement programs and initiatives. Innovate solutions to minor quality system gaps and participate in continuous improvement projects.
- Responsible for revising established processes and procedures which may impact multiple functions or regions.
- Performs other duties, as assigned
- Bachelor’s Degree or higher
- Specialist (3-5 years) and Senior Specialist (5+ years) of experience in cGMP supplier and materials management, preferably in a quality assurance role.
- Strong knowledge of cGMP inventory management systems, particularly SAP.
- Strong collaborator, internally and externally, with exceptional time management and organizational skills
- Proven team player, with the ability and desire to grow within the CBM organization.
- Excellent written and verbal communication skills
- Excellent analytical, prioritization, multi-tasking, and communication skills.
- Successfully drive projects forward to meet program/project deliverables
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills
- Ability to work effectively on cross functional teams
- Must have the ability to lift 25 - 50lbs