Carolyn Tomlinson

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

Carolyn’s Areas of Expertise

• Quality Management Systems – Has created, implemented, managed, and remediated QMS processes compliant with ISO 13485, ISO 9001, FDA 21 CFR 820/211, Canadian MDR, EU MDR/IVDR, and more.
• Auditing – Has conducted internal and supplier QMS audits; hosted Regulatory Authority inspections, and Notified Body and customer audits; managed internal and supplier audit programs; and trained new internal and lead auditors.
• Training – Has created and delivered engaging and effective in-person and virtual, instructor-led training for a variety of QMS topics, including auditing, supplier quality, risk management, NC/CAPA, root cause analysis, and overall QMS requirements, among others.

Highlighted Experience

• Led EU MDR transitions for multiple clients, including product technical documentation and QMS process creation and updates for compliance with new and changed regulatory requirements, MDCG guidances, and Annex XVI Common Specification requirements.
• Managed front- and back-room operations for multiple FDA facility inspections of an aseptic processing manufacturing site forsterile contact lens solutions and OTC ophthalmic products under 21 CFR Part 820 and 21 CFR Part 211 regulations. Also, managed all Notified Body and customer (private label manufacturing) audits to ISO 13485 and ISO 9001 for the same facility.
• Led the mitigation of a warning letter and multiple Form 483s to successful conclusion for clients through effective root cause analyses and CAPA planning and execution.
• Led the development, implementation, and ongoing management of the quality management system for two start-up manufacturing facilities.
• Served in leadership roles for multiple manufacturing facilities ($10 million to $300 million revenue) with responsibility of all aspects of the QMS and management of QA teams with 2 to 60-plus employees.
• Developed a standardized data collection system for product and supplier nonconformance information, and redesigned the supplier nonconformance process to improve its effectiveness and efficiency.