Contact Information

T: 905.363.1182 x.248
F: 905.542.7981

TF: 1.877.877.5152 x.248
M: 416.562.8189

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
Download Printable CV

Director Compliance Services

With over 20 years experience, Aaron is able to draw on a broad knowledge base gained from the food, water, and pharmaceutical (Drug, Natural Health Product, Active Pharmaceutical Ingredient [API]) industries. With a seasoned expertise, and the ability to focus on both prompt onsite issue resolution and project management, Aaron is well-suited for complex Quality Assurance, Quality Control, and Validation assignments, both at the contributor and leadership level. Previous employers include GlaxoSmithKline and DEC Manufacturing.

Skills and Highlights

Quality Assurance

  • Acted as Director of Quality for a large pharmaceutical company (approx. 400 employees), making day to day quality decisions and remediating quality systems
  • Create Quality Systems for the Importation and disposition of Drug and Natural Health Products from Canadian, Mutual Recognition Agreement (MRA) and foreign sites
  • Manage and resolve GMP relevant investigations; such as production, equipment, environmental monitoring, customer complaints, using risk analysis techniques (FMEA) and other root cause analysis techniques
  • Collate and review Manufacturing and Importer Annual Product Quality Review (APQR) documents, environmental monitoring summaries, perform statistical process and stability trend analyses
  • Initiate and complete product recall and associated destruction and return processes
  • Effectively manage change control program
  • Manage supplier qualification, including for revised compendia requirements, and for multiple material sources
  • Approve Quality Manual documentation, including manufacturing documents, specifications, quality agreements
  • Host Inspections from supplier audit team and regulatory bodies (Health Product and Food Inspection Branch (HPFBI), Food and Drug Administration (FDA), and Brazilian Health Inspection Agency (ANVISA), International Standards Organization (ISO), and Agricultural Compounds and Veterinary Medicines (ACVM)
  • Manage Health Canada/Client relationships and provide product and quality system related responses and/or coordinate Clarifax and related requests from Health Canada Therapeutic Products Division (TPD) and Natural and Non-Prescription Health Product Division (NNHPD)
  • Collate Quality Assurance Report (QAR) documentation for NNHPD site license annual renewal
  • Manage Validation Master Plan program activities

Quality Control

  • Conduct, review and approve In-Process, Finished Product testing for Food, Water, Raw Materials, and Finished Product, using  a variety of analytical instrumentation (e.g., HPLC, Dissolution, wet chemistry, and microbiological techniques)
  • Transfer analytical test methods (and associated method validation/verification activities) for use in the Quality Control laboratory
  • Manage water (USP Purified, Deionized, Ultrapure) water systems
  • Manage Laboratory, Out of Trend, and Out of Specification investigations
  • Conduct Environmental Monitoring and analysis
  • Maintain Laboratory LIMS data (methods, stability studies, specifications) and systems Develop electronic tools and metrics for quality system management (e.g., stability program placement of variants in bracketing and matrixing)
  • Approve test data pertaining to QC equipment qualification/maintenance/calibrations, inbound and outbound laboratory consumables, standards and chemical suitability
  • Utilize phase contrast microscopy, biochemical and computer tracking techniques to collect, collate, and statistically analyze data for research publication

Auditing

  • Conduct self-inspections (including application and computer systems) and supplier quality audits for fabricator, packager, labeler, warehouse and test sites to evaluate compliance with Health Canada Good Manufacturing Practices (GMP) requirements
  • Provide inspection report responses, follow-up reports and team updates
  • Conduct third party vendor compliance assessments

GMP Training

  • Develop and deliver GMP training materials for all company participant levels
  • Provide team, and one on one coaching and mentoring, based on compliance objectives (e.g., QA/QC system Investigation, Validation, Microbiological training)
  • Create forums for internal quality approval community of practice to ensure consistent application of quality principles across multiple company sites
  • Prepare company newsletters for reinforcement of training principles, system adoption, and host effectiveness check sessions

Technical Writing

  • Prepare all Quality Manual documents, including Procedures, Test Methods, Protocols (e.g., Stability, Validation Protocols and Reports, Environmental Monitoring, Annual Product Quality Reviews, Master Production Documents), Quality Agreements, Specifications, and associated Reports
  • Prepare Quality System gap analysis, risk management and compliance path documents
  • Prepare product evidence-related justification documents; such as stability profile and product temperature impact, process validation, and product process remediation
  • Provide management summaries, including metric analysis, remediation (e.g., Corrective and Preventive Action) plan alternatives and cost/benefit analysis
  • Prepare project management documents; such as system migration plans and scheduling (Gantt)

Validation

  • Manage prospective, concurrent and retrospective validation; for systems such as Manufacturing, Packaging Equipment, QC and Environmental Instruments, and Computer systems
  • Manage computer validation and verification testing for LIMS, manufacturing ERP, warehouse management, IT systems (application, infrastructure, e.g., SAP, Trackwise )
  • Write and execute Distribution Centre temperature (mapping) validation documentation

Regulatory

  • Facilitate quality system responses to revised United States Pharmacopoeia/European Pharmacopoeia (USP/EP) general chapter and product monograph requirements (e.g., <61>, <62> for microbiological testing and <467> residual solvents)
  • Prepare finished product data summaries for post-market submissions, USP monograph submissions
  • Review and evaluate previously conducted stability and efficacy studies for compliance with Health Canada Guidance Documents and Product monographs
  • Establish testing expectations for new and internally transferred products related to New Drug Application, and Certified Product Information Document (NDA, CPID) and multi-country marketed requirements
  • Prepare and liaise with Health Canada (TPD, NNHPD, HPFBI) product related clarifications and site license issues within requested timelines
  • Review Product Technical Files/ Product Quality Summaries to determine validation and transfer criteria
  • Review and advise on Client Health Canada communications, audit responses, and associated supporting documentation

Management

  • Manage quality system and business project objectives from inception to post-review stages
  • Provide QC leadership for finished product and stability testing teams
  • Manage Human Resources for QC laboratory, including personnel recruitment and management, performance evaluations
  • Provide mentoring and coaching for employee, and management groups
  • Manage QC laboratory budgeting, and materials management.
  • Establish business and quality system performance criteria, metrics and reporting tools (e.g., milestone reporting, hour accounting)
  • Manage and progress multiple projects with interrelated timelines and dependencies to completion
  • Codify company Enterprise Resource Planning (ERP) and Warehouse Management (WMS) reporting tools to ensure consistency of production and quality systems reporting

Computer Skills

  • Productivity: MS Access, Visio, Project, Libre Office
  • Resource Planning: SAP (ERP, MERPs)
  • IT Infrastructure: MS Server 2003, 2008 R2, 2012 R2, Hypervisor
  • LIMS and Quality Systems: SAP, Trackwise, Velquest Smartlab, LABC21
  • Document Management: Documentum, E-docs, Nugenesis
  • Training Management: Plateau Learning
  • Instrumentation Software: Empower, Sensitech, Infitrak, Vaisala Velquest, TempTale

Awards, Recognition and Achievements

  • Ensured anti-viral pandemic medicine was quickly distributed to the market by aligning information from multiple sources (quality site, technical, regulatory, production and supplier) to achieve a compliant disposition of product in less than six weeks
  • Remediated client sites with critical (multiple risk one observations) compliance deficiencies

Education

  • Bachelor of Science (Technology), University of Waikato, Hamilton, New Zealand

Continuing Education Highlights

  • Kepner-Tragoe: Problem Solving and Decision Making
  • Waters Corporation: Advanced Empower training
  • Lean Sigma: Advocate training
  • United States Pharmacopoeia: <905>: Uniformity of  Dosage Units
  • MS Excel: Advanced training
  • Data Integrity