Timothy Johnson

Tim advises clients on complex quality and regulatory issues across the organization including strategic direction, quality management systems, process controls, regulatory imperatives, risk management and IT solutions.

Tim has over 25 years of experience across the Life Science industry. With a focus on global transformation programs, Tim provides a unique understanding of the compliance environment and delivers organizational quality driven value. Tim has led many complex engagements including QMS design and implementation, Quality and Regulatory Affairs operating model design, Compliance as a Service, ERP implementations, Merger & Acquisition initiatives and Quality Audit.

Tim has a strong understanding of business strategy, program management and change management. Tim’s extensive practical and strategic business experience in combination with his technical acumen provide clients with solutions that achieve compliance while delivering process improvement and strategic goal alignment.

Engagement experience

• Led multiple global strategically imperative initiatives aligning quality and compliance processes and staffing to business directives and strategic direction. Involved regulatory and compliance process design, 3 levels of compliance defense structure, staffing needs, capability assessment, business alignment and labor arbitrage. Initiatives focus on achieving increased value and compliance across quality services.
• Led Quality Management System and support evaluation for global medical device manufacturer. Development of process flows, system requirements and support criteria. Supported system selection activities and outsource contracting for post-market surveillance.
• Led Regulatory Affairs transformation assessment for EPA and FDA regulated manufacturer. Performed maturity model assessment, technology GAP and resource staffing review to identify areas for improvement to align to strategic growth targets.
• Led managed service engagement in support of global quality deviation and CAPA management for global medical device manufacturer. Developed improvements in process, reporting and achieved established goals for closure. Enabled through RPA and advance analytics to identify trends and support proactive mitigations.
• Led Training and qualification initiative to align with compliance regulations and change management. Developed reporting with connections to training system, leaning management and HR. Real time dashboards supported compliance reporting and identification of mitigation areas.
• Led divestiture processes associated to IT compliance at a global pharmaceutical manufacturer. Including, spin process development, protocol development, global support structure definition and associated training.
• Led development and deployment of global compliance center at a global pharmaceutical manufacturer. Center provided support for validation, documentation and guidance for system recovery processes post cyber incident.
• Led global quality and compliance assessment in global pharmaceutical and medical device firm to determine risk and exposure and provide clients with strategic observations and recommendations. The areas focus included pre-clinical, clinical, regulatory, complaint management, manufacturing, supply chain and information technology.
• Led quality transformation for global pharmaceutical, medical device and consumer product manufacturer. Developed business case for organizational design shift aligned to business needs and strategic direction. Performed activity process review and redesign. Performed analysis of staffing needs and modeling for labor arbitrage.
• Led global compliance initiatives in support of SDLC management, quality protocol development, CAPA resolution and deviation management. Processes streamlined to reduce manual processes and increase accuracy.
• Led global Track and Trace Serialization implementation at global biologic and pharmaceutical manufacturer. Provided strategic oversite, leadership and framework to the program which included implementation of cloud-based solutions, new technologies for effective and efficient data collection both intra an extra network, ensuring compliance for cGMP requirements and country regulations, and system validation processes and procedures.
• Led global ERP implementations at Global Generic Pharmaceutical manufacturer. Provided strategic direction, program leadership and process design oversight. Established global template designs and led deployment across APAC, EMEA and North America. Established compliant process aligned with cGMP, SOX and HIPPA requirements.
• Directed Merger and Acquisition activities culminating in manufacturing, financial and quality process harmonization and technical system rationalization for a global generic pharmaceutical manufacturer. Involved 11 sites across 3 continents. Landscape separation design and supervision of the technical separation activities. Additionally, provided program management for establishing North American ERP support center.
• Design and deployment of ERP validation process enabling consistency across local, regional and global compliance for a global pharmaceutical manufacturer.