QA Compliance and Computer Validation Manager / Senior Consultant with 27 years' experience in FDA regulated environments. Agile, results oriented leader with strong communication, and organizational skills.
Solid dosage, parenteral, laboratory, animal health, and medical device environments.
Compliance, Quality Assurance, Computer Validation, Equipment Validation, Risk Assessments, and Quality Audits.
Subject matter expert - US 21 CFR Part 11 - Data Integrity
Experienced as Validation Manager, Team Lead, Project Manager, team resource and individual contributor.
Full systems development life cycle experience (SDLC) per ISPE - GAMP 5 Risk Based Approach to Compliant GxP Computerized Systems. Includes developing and maintaining Validation Plans/Policies, Formal Risk Assessments, Validation Project Plans, Specifications, Design Review, Commissioning Documentation, SOPs, Validation Scripts, preparing Validation Reports and Change Control within GxP environments.
Equipment and room qualification including clean utilities (WFI, Pure Steam, CIP, SIP etc.) and equipment (fillers, autoclaves, bioreactors, lyophilizers, fermentors, mixers, agitators, purification and ultrafiltration systems etc.).
Controls and automation commissioning, validation, and quality compliance specialist including software, distributed controls systems (DeltaV), manufacturing execution systems, and PLC systems.
Enterprise Resource Planning and software system validation including SAP, Documentum, Compliancewire, Customer Relationship Management, Pharmacovigilgence, MasterControl, etc.
Provides regulatory and operational risk assessments that allow clients to proactively manage risk and achieve regulatory compliance for Manufacturing, Medical Devices, Clinical, Lab and Quality related projects following 21CFR Part 11, Part 58, Parts 211, Part 820, GAMP 5, ASTM E-2500, Part 600, IEC 62304, ISO 14971, ISO 13485, International Standards (Europe and US).
Strategic implementation and alignment consultant with over 15 years’ experience in managing personnel and capital projects.
Consent Decree remediation experience.
Bachelor of Science
Degree - Bachelor of Science
Degree - Master of Business Administration
December 2023 - Present
Senior Computer Validation Engineer
Responsibilities include:
- Validation of Ceva's Building Management System (BMS).
- Validation of media fill and media hold systems.
March 2022 - October 2023
Quality Assurance - New sterile syringe and vial filling lines
Responsibilities include:
- Reviewing and approving all validation deliverables
- Identifying gaps from regulatory perspective
- Ensuring compliance with TFS SOPs
September 2019 - March 2022
Quality Assurance - Information Technology (QA IT)
Additional responsibilities include:
- Reviewing and approving validation deliverables
- Identifying gaps from regulatory perspective
- QA for DeltaV
July 2018 - September 2019
Software Validation Engineer - Senior Consultant providing enterprise computer system validation expertise. Projects include Valgenesis and Johnson Controls P2000 Security Management System.
Additional responsibilities include:
- Shaping and authoring validation deliverables
- Executing validation strategy
- Prioritizing the risks associated with the use of Regeneron systems
- Identifying gaps from regulatory perspective
- Cloud based validation expertise
July 2016 - July 2018
Software Quality Assurance Engineer - Senior Consultant providing QA Computer System compliance review and approval of validation documents for medical device company. Projects include SaaS CRM (Salesforce.com) and Model N SFDC application.
Additional responsibilities include:
- Shaping validation deliverables (Agile Development Methodology)
- Providing offshore QA oversight and informal training
- Identifying gaps from regulatory perspective
- Cloud based validation expertise
December 2015 - July 2016
Senior Consultant providing GxP Computer System QA compliance support as Project Manager for Oxford International. Validate VMware vSphere Infrastructure system, High Availability / Disaster Recovery system with virtual servers and cloud base applications.
September 2015 - December 2015
Senior Consultant providing Quality Assurance oversight with signature authority for the validation of a new manufacturing facility in Bend, Oregon. Projects include Master Control DMS and Apogee Building Management System.
February 2015 - September 2015
Senior Consultant responsible for the validation of Mint Lesion a DICOM 3.0 a cloud-based compliant PACS application that supports radiologists and oncologists in assessing and evaluating the effectiveness of cancer therapy.
February 2014 - February 2015
Senior Consultant responsible for the validation of computer systems including a custom Laboratory Information Management System (LIMS). Responsibilities include consulting for FDA Compliance on LIMS and performing vendor audits.
June 2012 - February 2014
Senior Consultant responsible for the validation of process, equipment, utility, automation and computer systems. Responsibilities include consultation for FDA Compliance and Quality Systems including internal audit to assess compliance with CFR 21 Part 211, Part 820, and Part 11. SME for GAMP 5 risk assessment and software development life cycle activities.Clients Include:
- Hospira, Inc., Rocky Mount, North Carolina (Remediation Director for FDA audit observations)
- Arkema, Inc., Memphis, Tennessee (Process, equipment, and computer validation for API (Delta V, PROVOX, Pi Historian)
August 2004 - June 2012
Manager of Compliance responsible for the implementation, design, administration, coordination, documentation and performance of utility,automation and computer system validation activities along with managing two direct reports.
Projects include; InfoMed (complaint handling enterprise software), Purified Water System, Building Management System, SAP Validation, Network Qualification, Documentum, HP Quality Center, eInfoTree, Sales Force Automation (SFA) software and hardware validation conforming to PDMA regulations, Liquent InSight FDA Electronic Publishing System, Argus Drug Safety system, QScan Signal System, StarLIMS, and Empower Chromatography Data System.
Authored corporate policies for network qualification, CFR 21 Part 11, and departmental policies for computer systems validation including software development lifecycle documentation. Subject matter expert (SME) GAMP 5, and Part 11.
September 1997 - August 2004
Validation Engineer. Responsiblities including authoring and executing equipment, utility, automation and computer system validation documents while managing computer validation personnel for various clients. Clients Include:
- IVAX Research, Inc., Garden Glades, Florida
- Wyeth Pharmaceuticals, Richmond, Virginia (Plant shutdown)
- Amgen, Providence, Rhode Island (Delta V)
- Avecia Biotechnology, Inc., Milford, Massachusetts
- Pharmacia (now Pfizer), Chesterfield, Missouri
- Aventis Behring, Kankakee, Illinois (Consent Decree Remediation 2001)
- Bayer, Shawnee, Kansas
- Alcon Laboratories, Inc., Fort Worth, Texas
- Wyeth-Ayerst Laboratories, Inc., Marietta, Pennsylvania
May 1993 - September 1997
Engineering Project Manager, Consulting Engineer and project manager for major pharmaceutical projects, equipment, HVAC and building management.