Woody Johnson
Shawnee,KS
Summary
Proactive, hands-on, highly skilled, and results driven QA subject matter expert (SME) with expertise in QC and regulatory compliance. Over thirty years of experience primarily in the pharmaceutical sector (primarily small molecule, solid dosage and API manufacturing but also biologics). A proven track record of successfully leading and managing the quality system, CMC processes and regulatory compliance, GxP audits (including PAI), AND internal and external auditing programs to support both commercial and noncommercial activities. Extensive global QA experience (Canada, Europe) and a thorough knowledge of GxP regulations 21 CFR 11/210/211, ICH guidelines, and international regulatory requirements (e.g., EU/EMA, Health Canada). Excellent problem solving, negotiation, communication, collaboration, and interpersonal skills.
Overview
23
23
years of professional experience
Work History
DIRECTOR, QUALITY ASSURANCE
LLOYD, Inc. (GMP, GCP)
Shenandoah, IA
01.2013 - Current
- Responsible for leading and managing the Quality Management System (QMS), QA and compliance staffs
- Direct management oversight for product release, vendor quality, internal and external auditing, CAPAs, change management, deviations and OOS investigations, and regulatory (CMC) submissions
- Management oversight and leadership of the GxP training programs
- Manage the QMS to support commercial and development activities
- Oversee the release or rejection of all materials for GMP and GXP processes
- Manage, review and approval of all non-conformances (OOS, OOT, deviations)
- Oversee, review and approve all GxP documents including quality agreements
- Serve as a site compliance expert and provide guidance on the interpretation and application of U.S
- And global regulatory requirements (i.e., EMA, Health Canada, ANVISA)
- Chair and lead Quality Management Review and Material Review Boards
- Manage quality metrics, gap assessments, risk assessments, and risk mitigation
- Lead, manage, and host all regulatory inspections including regulatory preparedness and responses
- Direct and manage GxP auditing programs inclding auditor training and audit scheduling
- Responsible for leadership, training, and oversight of the internal and external Quality Auditing program
- Manage the review and approval of all regulatory (CMC) submissions
- Manage all third-party compliance (contract labs, CMOs) including supplier qualification
- Hire, manage, develop and mentor QA and compliance staff members
- Prepare, review, and approve departmental budget and capital expenditures.
SENIOR QA COMPLIANCE CONSULTANT
Validant Consulting Inc.
01.2006 - 01.2013
- Provide compliance and quality assurance management and oversight for commercial drug manufacture, drug product development, Quality Control (QC) operations and contract manufacturing operations (CMO)
- Serve GMP subject matter expert to R&D and Commercial Operations
- Expert review of all quality records including batch records, deviations (OOS), and change controls
- Manage all QA disposition activities for commercial drug products and clinical trial materials (CTM)
- Closely monitor and manage quality system performance and provide periodic quality metrics reports including CAPA status and trending to Executive Management
- Identify and manage quality system improvements based on gap analysis, develop action plans for remediation, and implement corrective actions to mitigate compliance risks or escalate to Executive Management as appropriate
- Conduct GMP audits of contract labs, contract manufacturers, and suppliers
- CMC review of regulatory submissions, annual regulatory reports, and annual product reviews
- Author QA SOPs and policies including quality manual and quality (technical) agreements
- Facilitate and coordinate regulatory inspections and responses to regulatory agencies (FDA, EMA, Health Canada).
EXECUTIVE DIRECTOR, R&D QUALITY ASSURANCE
UPM Pharmaceutical, Inc. (GMP)
Baltimore, MD
01.2004 - 01.2005
- Oversaw all quality assurance activities in support of drug development for contract manufactured clinical trial materials
- Managed all operational aspects of Quality Assurance including auditing, product testing, material reviews, change (control) management system, document control system, and supervision of QA staff (three direct reports)
- Managed GMP and DEA compliance, and internal auditing
- Developed and executed corrective action (CAPA) and internal and external auditing programs
- Provided feedback to department heads regarding audit findings, CAPAs, and resolution of deviations
- Successively managed all DEA, regulatory, client, and third party inspections and follow-up responses
- Directly responsible for all FDA and client audit preparations, responses and follow-up
- Oversaw qualification and validation activities
- Managed and administered the internal audit program and training for auditors
- Managed tracking and trending of Quality Metrics for contractor performance and product quality
- Managed and directed CAPA and continuous improvement system.
DIRECTOR, QUALITY AND COMPLIANCE
Aventis Behring LLC (GMP)
Kankakee, IL
01.2002 - 01.2003
- Oversaw auditing, product disposition and documentation functions; coordination and preparation of site regulatory inspections, complaint handling, and corrective action programs (CAPA), material reviews and deviations, compliance remediation (consent decree), and preparation of annual budget
- Managed five direct and fifteen indirect reports
- Lead site inspections including pre-approval and routine GMP inspections
- Oversaw the implementation of electronic documentation system
- Enhanced audit program by developing internal auditor certification program
- Managed the development, review and approval of all quality system documents
- Developed and authorized the implementation of site policies and procedures (SOPs).
Education
Master of Science - Chemistry
ARKANSAS STATE UNIVERSITY
Bachelor of Science - Chemistry
ARKANSAS STATE UNIVERSITY
Skills
- Quality System Management
- Regulatory Inspections
- CMC and Regulatory Compliance
- Analytical Method Validation
- Process Validation
- Third Party and CDMO Compliance
- GxP Auditing
- Supplier and vendor Qualification
- CAPA Management
- Tech Transfers
- Contract and Vendor Management
- Verbal and Written Communication
- People Management
Affiliations And Memberships
- Regulatory Affairs Professional Society (RAPS)
- Drug Information Association (DIA)
Training
- Project Management
- Six Sigma
- Statistical Process Control
- Electronic Common Technical Document (eCTD)
References
References available upon request.
Timeline
DIRECTOR, QUALITY ASSURANCE
LLOYD, Inc. (GMP, GCP)
01.2013 - Current
SENIOR QA COMPLIANCE CONSULTANT
Validant Consulting Inc.
01.2006 - 01.2013
EXECUTIVE DIRECTOR, R&D QUALITY ASSURANCE
UPM Pharmaceutical, Inc. (GMP)
01.2004 - 01.2005
DIRECTOR, QUALITY AND COMPLIANCE
Aventis Behring LLC (GMP)
01.2002 - 01.2003
Master of Science - Chemistry
ARKANSAS STATE UNIVERSITY
Bachelor of Science - Chemistry
ARKANSAS STATE UNIVERSITY