Quality Systems Specialist
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Quality Systems Specialist

King of Prussia, PA

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.

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.

Summary

The Center for Breakthrough Medicines is looking to add a Quality Systems Specialist to their Quality Assurance Team. The Quality Systems Specialist will provide a broad scope of technical knowledge to independently analyze risk, troubleshoot complex issues, support quality systems, and site compliance. The role will require applying expertise and regulatory knowledge to support change and risk management, including applying scientific and technical innovation as it pertains to Clinical and Commercial Manufacturing. The Quality Systems Specialist develops a lifecycle and systems-based approach to the design and implementation of phase appropriate Quality Systems and process controls. This role frequently interacts with area management, direct manager, QA staff and cross-functional peers to gain alignment on sound quality decisions on both clinical and commercial GMP-related issues.

Responsibilities

  • Critically review various documentation types to ensure completeness, accuracy, and compliance, including but not limited to regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request for Proposals, SOPs, master plans, deviation investigations, CAPAs, and change controls
  • Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product
  • Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team Plan, schedule, and conduct internal quality system audits per audit schedule. This includes reviewing prior internal audits and regulatory inspections, reviewing procedures, processes, and activities in creating the audit plan
  • Maintain Quality Systems including but not limited to CAPAs, Change Control, Effectiveness Checks, and Management Review in support of site operations
  • Support Regulatory and Client Audits, responses, and associated CAPAs
  • Manage Supplier Quality Program, supplier notification changes to ensure the impact is thoroughly assessed before implementation
  • Liaise with suppliers in addressing nonconformities through thorough investigations
  • Maintain a Supplier Corrective Action process and liaise with suppliers to resolve quality issues
  • Recognize and promote quality and compliance improvement
  • Support inspection readiness strategy and activities and serve as a subject matter expert in quality systems
  • Contribute to the drafting and review of regulatory submissions

Qualifications

  • Bachelor s Degree in Scientific or related fields preferred
  • 5+ years of cGMP Quality experience
  • Strong Clinical and Commercial GMP experience required
  • Experienced with US pharmaceutical regulations, ISO standards and EU Guidelines
  • Expert Knowledge and application of GMP principles
  • Proficiency in using Quality Management Systems e.g., Veeva, as well as other software systems e.g., LiMS, SAP
  • Excellent communication skills: oral/written and listening
  • Excellent facilitation and presentation skills
  • Personal Competencies: Self-awareness, Integrity, Judgment, Decision making, Vision, and Adaptability
  • Interpersonal skills: team building, consensus building, conflict resolution
  • Critical analytical skills, strong verbal and communication skills
  • Must be able to evaluate data summaries and conclusions critically

Compensation: TBD

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