COURTNEY CRIDDLE
West Chester,PA
Summary
Seasoned Quality Assurance Manager with over 25 years of experience supporting the manufacture of cell and gene therapies, including plasmid DNA, viral vectors, transduced cell manufacturing, biopharmaceuticals, sterile filling, medical devices, and vaccines. Proven track record in overseeing product quality at contract manufacturing organizations in the United Kingdom, Austria, Japan, Germany, and the United States for more than 12 years. Expertise in process automation and computer validation for efficient and compliant operations.
Overview
25
25
years of professional experience
Work History
DIRECTOR
Trialspark / Formation Bio
05.2022 - 10.2024
- Developed the GMP quality assurance program at Trialspark, including development of appropriate procedural documents
- Oversaw and performed batch record reviews including QA release of clinical trial materials
- Oversaw and performed QA review of CGMP-related documentation, such as specifications, test methods, validation and technical protocols and reports, stability protocols and reports, master and executed production records, deviation/investigation/out-of-specification reports, etc
- Collaborated with and provided Quality oversight to Contracted manufacturing and packaging operation partners, including supporting the development and maintenance of Quality Agreements
- Managed identification, tracking and reporting of technical product complaints, including training personnel in identification of such complaints
- Authored and demonstrated appropriate Quality oversight of special protocols and investigations resulting from GMP Events including root-cause analysis and assessment of impact to product quality, ensuring appropriate CAPA actions are identified and addressed until closure
- Directed and implemented the GMP Change Control process ensuring alignment amongst stakeholders
ASSOCIATE DIRECTOR
Sio Gene Therapies
03.2021 - 04.2022
- Provides CMC quality assurance operations/compliance subject matter expertise, continuous quality oversight, support, and timely resolution of quality issues as it pertains to external global contract manufacturing and studies in support of CMC project teams and regulatory submissions for pipeline products
- Escalates significant quality/compliance issues to the Quality Head and other area Management
- Develops, implements, and maintains internal QMS procedures (Disposition, Audits, Complaints and Recalls, Quality Agreements)
- Executes external GMP audit execution, reports, and CAPA Management
- Supports regulatory inspection activities and generation of responses to related observations
- Develops and/or executes quality review and approval of: Production and quality-related investigations and deviations, OOS and laboratory investigations, CAPA management and change management of Customer complaints/inquiries, Audits and quality agreements, Risk assessments, CMC documentation/records
CELL AND GENE THERAPY QA MANAGER
GSK
12.2007 - 03.2021
- QA product oversight of 11 CMOs in the areas of Cell and Gene Therapies (plasmids, vectors, and cell manufacturing), and Biopharmaceuticals (drug substance, drug product, and device product), including: Due Diligence assessment of potential contract sites, Management of cross-functional matrix teams, Development and negotiation of Quality Agreements, Review of contracts, Leading regular joint quality review meetings, Review and approval of product specifications, master and executed batch records, change controls, deviations, certificates of analysis, and other quality-related documentation
- Performing technical risk assessments, audits, and batch record reviews
- Performing disposition of over 100 drug substance, drug product, and device product batches
- Audit support as both lead auditor and co-auditor
- CAPA Management
- Management of a quality integration team following GSK purchase of a contract manufacturing site
- Implementing a program for disposition of cell and gene therapy products, including viral vectors, transduced cells, and plasmids
- Implementing a program for disposition of biopharmaceutical drug product
- Establishing a procedure for contract manufacturing quality
PRINCIPLE QUALITY ASSURANCE SPECIALIST
GSK
06.2004 - 12.2007
- Primary QA support for computer validation activities within the biopharmaceutical manufacturing facility
- During biopharmaceutical manufacturing facility decommissioning, refurbishment, and start-up, performed quality review of computer validation documentation including requirement and design specifications, IOQs, traceability matrices, technical investigations, and SOPs
- Performance of multiple internal audits and supplier audits
- Managed audit control room during internal and external audits
- Supported electronic deviation system start up as the QA lead
- Performed QA project support to computerized system projects, including a deviation system, a document management system, and a laboratory data system
- Lead Trainer for classroom sessions
QUALITY ENGINEER
GSK
09.2003 - 06.2004
- Provided quality assurance support for production of parenteral cephalosporins, including deviation and customer complaint investigations, change controls, and CAPA for manufacturing, sterile filling, and packaging
- Managed audit control room during multiple FDA audits and provided quality assurance support during customer audits
TECHNOLOGIES SYSTEMS ANALYST
GSK
05.2002 - 09.2003
- Development of Computer Validation Strategy: Assessed systems for compliance status and developed corrective actions to bring systems into compliance where required
- Project Support: Upgraded building automation system to ABB Distributed Control System (DCS) and configured new Met One Particle Monitoring System to interface with new DCS
MANUFACTURING FACILITATOR
Merck
06.1999 - 04.2002
- Direct support to production activities through troubleshooting, investigation assistance, development and implementation of change control packages, and updates to process automation documentation
- Investigation and resolution of all automation related production issues and created enhancements to the functionality of the following systems: PLC/SCADA Purification Skid, Delta-V, Robotics, and Wheaton Roller Bottle/Cart System
- Management of process improvement projects, including system installation, equipment replacement, and facility expansion
Education
Bachelor's degree - Mechanical Engineering
Lehigh University
06.1999
Skills
- CAPA management
- Due Diligence
- Audit
- Change Management
- Complaint Handling
- Troubleshooting
- Investigation assistance
- Project Support
- Building Automation
- Process Improvement
- GMP quality assurance
- CMO management
- Decision-making
- Relationship building
- People management
- Project management
- Team management
- Change management
- Contract and vendor management
- Problem-solving
- Multitasking and organization
Accomplishments
Global Quality interface with experience managing over 16 contract manufacturing organizations / suppliers in
various roles in both cell and gene therapies, biopharmaceuticals, and small molecules.
- Establishing, maintaining, and developing the quality relationship between GSK and external suppliers
- Managing all Quality Assurance related activities in support of contract manufacturing of biopharmaceutical and cell / gene therapy products, including risk management, change control, deviations, batch record review, batch release, CAPA, and Quality Agreements.
- Development of the disposition process for cell and gene therapy products, including viral vectors, transduced cells, and plasmids.
- Development of a two-stage release process for transduced cells release, allowing for reduced release cycle times, to enable product to be released to the patient more quickly
- Development of a release process for release of transduced cells for which the batch may have not met dose,but for which there is unmet medical need as requested by the physician and agreed with the regulatoryagencies.
- GSK Certified Auditor leading internal and external audits, including GMP and Due Diligence audits
- Aseptic Manufacturing Training and Device Regulations Training
- Experienced as a team leader with direct reports, in addition to leading matrix teams
Timeline
DIRECTOR
Trialspark / Formation Bio
05.2022 - 10.2024
ASSOCIATE DIRECTOR
Sio Gene Therapies
03.2021 - 04.2022
CELL AND GENE THERAPY QA MANAGER
GSK
12.2007 - 03.2021
PRINCIPLE QUALITY ASSURANCE SPECIALIST
GSK
06.2004 - 12.2007
QUALITY ENGINEER
GSK
09.2003 - 06.2004
TECHNOLOGIES SYSTEMS ANALYST
GSK
05.2002 - 09.2003
MANUFACTURING FACILITATOR
Merck
06.1999 - 04.2002
Bachelor's degree - Mechanical Engineering
Lehigh University
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