Quality Systems Manager

King of Prussia

Summary

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[1]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. The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Responsibilities

The Discovery Labs is seeking an experienced Quality Systems Manager to play a critical role in delivering and maintaining a Quality Management System (QMS) that enables innovation, productivity, continuous improvement, and adherence to applicable regulations. The Quality Systems Manager will be responsible for building impactful relationships and collaborations across the organization while relying on practical experience to advance a proactive strategy in a fast-paced organization.

Primary Responsibilities:

  • Provide quality ownership and oversight in the day-to-day managing of all aspects of quality management system in CBM’s eQMS systems (Veeva)– change control, deviations, effectiveness checks, risk management, lab investigations, supplier complaints, findings, and CAPA.
  • Monitor the overall site quality system effectiveness – continuous improvements, trending beyond metrics, lessons learned/knowledge management, and striving for operational excellence.
  • Create and provide training in support of the QMS e.g. GMP, GDP, Root Cause Analysis, Risk analysis tools
  • Collaborate with other subject matter experts across the GMP organizations to ensure end-user satisfaction with the eQMS system.
  • Understand and initiate configuration changes and updates to the eQMS Veeva system to accommodate CBM ways of working via change control
  • Actively participate and/or lead the preparation of Quality Management Reviews and Quality Improvement plans.
  • Propose, initiate and prepare SOPs and other governance documents.
  • Participate in Regulatory Agency Inspections and Client Audits
  • Review, approve and/or administer critical compliance documents in support of GMP and GTP operations according to Center for Breakthrough Medicines’ SOPs and regulatory requirements.
  • Represent Quality at designated cross-functional project/program team meetings.

Qualifications

  • Bachelor’s Degree in Life Sciences.
  • 7-10 years of relevant Quality experience including managing GxP quality systems in the Pharma/Biotech industry.
  • Solid understanding of industry regulation 21CFR 210, 211, 11, 820 as well as EU Guideline for Advanced Therapy and Medicinal Products.
  • Significant experience with both digital and paper based QMS solutions.
  • Diverse, Quality operations experience across functions in GMP including CRO/CDMO oversight activities.
  • Regulatory experience a plus

Physical Demands

Candidate should be able to lift 25lbs

Position may require standing for periods of time.

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