CBM

Part Time EE

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.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Summary

Center for Breakthrough Medicines seeks an intrinsically motivated quality professional with a growth mindset who will meet and exceed deadlines and quality expectations.

The QS Supplier Management Manager will be accountable to assist in implementing and maintaining the Supplier Quality Management program for Center for Breakthrough Medicines. The individual will provide quality oversight on compliance and Good Manufacturing Practice (GMP) that pertains to suppliers of material and components to meet CBM’s standards and regulatory expectations. The QS Supplier Management Manager will manage the end-to-end supplier qualification activities, including supplier evaluation, audit activities, supplier management and supplier requalification.

The QS Supplier Management Manager will support investigations pertaining to the supplier and ensure that deviations are addressed in a timely manner and that corrective actions meet company and regulatory expectations. The role will provide timely decisions and consultations in alignment with cGMP, CBM and regulatory guidelines.

Responsibilities

• Center for Breakthrough Medicines seeks an intrinsically motivated quality professional with a growth mindset who will meet and exceed deadlines and quality expectations.
• The QS Supplier Management Manager will be accountable to assist in implementing and maintaining the Supplier Quality Management program for Center for Breakthrough Medicines. The individual will provide quality oversight on compliance and Good Manufacturing Practice (GMP) that pertains to suppliers of material and components to meet CBM’s standards and regulatory expectations. The QS Supplier Management Manager will manage the end-to-end supplier qualification activities, including supplier evaluation, audit activities, supplier management and supplier requalification.
• The QS Supplier Management Manager will support investigations pertaining to the supplier and ensure that deviations are addressed in a timely manner and that corrective actions meet company and regulatory expectations. The role will provide timely decisions and consultations in alignment with cGMP, CBM and regulatory guidelines.

Qualifications

• Bachelor’s Degree or higher
• 7+years of experience in cGMP supplier and materials management, preferably in a quality assurance role
• Strong collaborator, internally and externally, with exceptional time management and organizational skills
• Proven manager, mentor, and team developer, with the ability and desire to grow an organization, and facilitate the dynamics of growth and achieving goals
• Excellent written and verbal communication skills
• Excellent analytical, prioritization, multi-tasking, communication, and strong leadership skills and the ability to work independently without supervision
• Prior experience preparing and presenting written and verbal reports to upper management and business unit heads
• 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
• ASQ CQA, CQE or CQM certification, preferred
• Strong influencing skills