PAUL W. BLACKWELL JR.
Gettysburg,PA
Summary
Quality and Regulatory Executive experienced in leading quality initiatives across medical devices, biologics, and pharmaceuticals. Achieved inspection-ready organizations and strengthened enterprise governance through transformation of quality systems to enhance product development and mitigate operational risk. Focused on delivering comprehensive quality and risk programs in support of national biodefense efforts and compliance with regulatory standards.
Overview
18
18
years of professional experience
Work History
Director of Quality Assurance & Control
BATTELLE NATIONAL BIODEFENSE INSTITUTE
Ft. Detrick, MD
01.2022 - Current
- Direct quality, risk, and compliance operations for a one-of-a-kind national BSL-4 biodefense laboratory, accredited to ISO 17025 and supporting federal law enforcement and national biodefense threat research.
- Lead a team of 8 Quality Specialists and manage a $2M budget.
- Serve as the liaison to DHS for quality control planning, risk management, and records management.
- Member of the Leadership Team, participating in strategic planning.
- Achieved 100% acceptance rate for laboratory method submissions by providing technical and quality guidance to Principal Investigators on assay development and validation.
- Built a digital enterprise risk management (ERM) program from scratch, including training functional risk owners, facilitating risk workshops, and developing KRI dashboards and governance procedures, improving lab compliance and reducing nonconformities by 40%.
- Transformed internal audit programs from compliance-focused to risk-based, implementing new methodologies that improved audit effectiveness by 30% and reduced critical findings.
- Lowered supply and resource costs 40% by integrating risk-based and validation bracketing principles into the corporate forensic laboratory proficiency testing schedule.
- A one-of-a-kind national BSL-4 biodefense laboratory, accredited to ISO 17025 and supporting federal law enforcement and national biodefense threat research.
Director of Supplier Quality, Engineering, and Quality Assurance
TYBER MEDICAL
Bethlehem, PA
01.2019 - 01.2022
- Managed quality assurance functions and supplier quality management for private label/CDMO medical device manufacturer, establishing foundational processes in start-up environment.
- Decreased QC inspection turnaround times by 50% and improved supplier First Pass Acceptance rates by 60% by implementing a QbD (Quality by Design) initiative.
- Directed supplier qualification, onboarding, and audits, ensuring compliance and quality standards across supply base.
- Managed CAPA system, nonconformance reporting, process validation management, and restricted substance and EU MDR site readiness.
- Managed quality assurance functions and supplier quality management for private label/CDMO medical device manufacturer, establishing foundational processes in startup environment.
- Worked closely with manufacturing, product development, engineering, procurement, regulatory, and QA teams on failure prevention and risk mitigation, especially in the areas of raw materials, components, finished goods, and services.
- Directed supplier qualification, on-boarding, and audits, ensuring compliance and quality standards across supply base.
- Managed CAPA system, non-conformance reporting, process validation management, and restricted substance and EU MDR site readiness.
Co-Founder/VP Quality & Regulatory Consulting
DIMS (DESIGN, INSPECTION, AND MANUFACTURING SPECIALISTS)
Macungie, PA
01.2019 - 01.2022
- Co-founded consulting firm providing quality system architecture, validation strategy, and regulatory readiness support for medical device manufacturers.
- Helping clients achieve ISO certification, preparing for FDA inspections, and design scalable QMS programs.
- Consulting firm providing quality system architecture, validation strategy, and regulatory readiness support for medical device manufacturers.
Quality Manager & Site Management Representative
KAVO KERR (DENTAL IMAGING TECHNOLOGIES CORP.)
Hatfield, PA
01.2018 - 01.2019
- Oversaw licensing, marketing, and legal compliance to support the development and sale of Class I/II medical devices and regulated, embedded software/firmware in the US, China, Japan, Brazil, Australia, and Canada.
- Directed and managed customer complaint handling, quality processes and systems relating to off-site customer service and technical support call centers.
- Managed an operational budget and supervised a staff of 8 quality engineers, analysts, and technicians.
- Guided field actions, complaint responses and investigations, adverse event activities, product holds, MDR functions, inspections, recalls, calibrations, metrology, quality engineering, and document control.
- Carried out medical device and annual radiation reporting.
- Spearheaded the successful ISO 13485:2016, IEC 60601 (CE Compliance), and MDSAP re-certification of sites in Pennsylvania and Georgia.
- Improved QC internal inspection and release turnaround times by 30% for i-CAT and KaVo 3D imaging machines.
- Increased site compliance scores and employee engagement scores from 50% to over 90% in one year by reengaging staff, identifying skill sets, reorganizing the department, and holding team-building events.
- Reduced overdue customer complaints by >60% within 90 days by streamlining the intake process and implementing a Complaint Detection Trend and Response process.
Senior Quality Manager, Quality Operations & Supply Chain, Clinical Trials Division
THERMOFISHER SCIENTIFIC
Allentown, PA
01.2016 - 01.2018
- Responsible for clinical packaging room quality, environmental monitoring, and clinical supply chain quality control.
- Managed quality, 21 CFR 210/211/820/MPA/USP compliance, and conformity to client requirements for investigational medicinal drug products.
- Supervised 4 quality managers and more than 30 indirect reports.
- Reduced OOT/OOS results by 60% in the packaging area by working with engineering on equipment performance.
- Led quality planning for disaster recovery after a significant weather event restoring clinical packaging operations within 6 weeks and ensuring no impact to client supply timelines.
Associate Director, Quality Assurance / Quality Control / Supplier Management
AESCULAP / IMPLANT SYSTEMS
Center Valley, PA
01.2014 - 01.2016
- Managed quality functions across 2 organizations, ensuring compliance with regulatory standards and enhancing overall quality assurance processes.
- Established the Supplier Quality Management Team and served as the QA representative for R&D engineering projects and coordinator for lab testing and analysis.
- Led qualification and validation of Class I medical instruments sourced from China and Germany, expanding private label portfolio.
- Served as the Corporate QA/QC/QE representative for 3 manufacturing sites.
- Supervised 9 quality engineers, supervisors, and analysts.
- Managed quality functions for 2 organizations.
- Improved the US design controls process by reorganizing the validation program and implementing quality planning, DOE, and engineering technical studies.
- Established Supplier Quality Management Team, serving as QA representative for R&D projects and coordinating lab testing and analysis to support product development.
- Reworked CAPA and NCR systems, improving response time by 60%, enhancing effectiveness of corrective actions and non-conformance management.
Quality Systems Compliance Manager / Quality Assurance Manager
MUSCULOSKELETAL TRANSPLANT FOUNDATION (MTF)
Jessup, PA
01.2009 - 01.2014
- Managed quality functions for human tissue bank processor (Allograft), ensuring compliance with 1271/AATB regulations (US, Canada, Australia), leading nonconformance investigations, coordinating external audits, addressing material and HCT/P tissue review board concerns, and overseeing policy design, validation, document control, and reporting.
- Served as liaison to regulatory bodies (AATB/TGA), customers, and business partners on quality matters, collaborating with vendors and suppliers to resolve quality issues and implement controls.
- Reduced deviations 70% and improved CAPA process by restructuring procedures and introducing 8D principles, change management system updates, root cause analysis training, and corrective action training.
- Increased product-to-distribution rate by 30% and improved the QA review process by 25% by reducing bottlenecks.
- Performed external audits of recovery partners, tissue distributors, and supply vendors to verify compliance with contractual obligations and ISO, FDA, BSI, AATB, and TGA standards.
- Processed human tissue in a regulated environment.
Education
Graduate course work - Quality Management
Florida Institute of Technology
BS - Biology, concentration in Cellular Biology & Chemistry
College Misericordia
Skills
- Regulatory Affairs
- 510k
- PMA
- FDA
- ISO
- EU MDR
- MDSAP
- GLP
- GMP
- Quality operations
- Quality Team Leadership
- Quality Control Processes
- GD&T
- Quality Engineering
- Validation
- IQ
- OQ
- PQ
- BSL-2
- BSL-3
- BSL-4
- Laboratory methods
- PCR
- Genomics
- Bacteriology
- Mass Spectrometry
- Immunology
- Aseptic Technique
- Vaccine Sterile-Fill Manufacturing
- RABS
- Quality Assurance
- Product Quality Assurance
- Process Optimization
Websites
Certifications Training
- Internal Auditor Certification: MDSAP/ISO 13485:2016; EU MDR 2017/745; ISO 17025:2017 (Exemplar Global)
- Advanced Process Based Auditing for Medical Device Manufacturers (Professional Quality Systems)
- Problem Solving Process (PSP) Certification (Kavo Kerr)
- Risk Management/FMEA: ISO 31000:2018 (ERM31000 Training and Consulting)
- Quality/Operational Excellence Management Training (ASQ)
Technical Analytical Skills
- Laboratory methods including PCR, genomics, bacteriology, mass spectrometry, and immunology supporting biodefense forensic investigation
- Experience with aseptic technique and supervising a vaccine sterile-fill manufacturing line (RABS)
- R&D and product development work for semiconductor thin-film deposition technologies (MBE/MOCVD/MOVPE)
Security Clearances
Active Top Secret / SCI Clearance, Department of Homeland Security
Core Competencies
Regulatory Affairs/510k/PMA, FDA/A2LA/ISO, EU MDR/MDSAP, GLP/GMP, Global Quality Operations, Enterprise Risk Management, Organizational Transformation, Cross-Functional Leadership, Design Controls/GD&T, Engineering/Validation, Validation (IQ/OQ/PQ), BSL-2/3/4 Lab Quality, Regulatory and Quality Frameworks: ISO 17025, 45001, 14001, 13485, 9001, 14971, 31000, 11737, 10993, 19011, 56001, 21 CFR (820, 58 (GLP), 100, 110, 210/211, Part 11) EU MDR 2017/745, MDSAP, FBI QAS, CE Marking
Timeline
Director of Quality Assurance & Control
BATTELLE NATIONAL BIODEFENSE INSTITUTE
01.2022 - Current
Director of Supplier Quality, Engineering, and Quality Assurance
TYBER MEDICAL
01.2019 - 01.2022
Co-Founder/VP Quality & Regulatory Consulting
DIMS (DESIGN, INSPECTION, AND MANUFACTURING SPECIALISTS)
01.2019 - 01.2022
Quality Manager & Site Management Representative
KAVO KERR (DENTAL IMAGING TECHNOLOGIES CORP.)
01.2018 - 01.2019
Senior Quality Manager, Quality Operations & Supply Chain, Clinical Trials Division
THERMOFISHER SCIENTIFIC
01.2016 - 01.2018
Associate Director, Quality Assurance / Quality Control / Supplier Management
AESCULAP / IMPLANT SYSTEMS
01.2014 - 01.2016
Quality Systems Compliance Manager / Quality Assurance Manager
MUSCULOSKELETAL TRANSPLANT FOUNDATION (MTF)
01.2009 - 01.2014
Graduate course work - Quality Management
Florida Institute of Technology
BS - Biology, concentration in Cellular Biology & Chemistry
College Misericordia