Claire has enjoyed a 20+ year career mainly in the Biopharmaceutical industry, where she has successfully led Teams through both startup challenges and also transformative change.
Claires career experience is underpinned by significant qualifications in including:
– Masters in Pharmaceutical Technology and Quality Systems (Hons)
– Higher Diploma in Quality Systems (QP) (Hons)
– B.Sc. In Applied Chemistry with Quality Management (Hons)
She has gained significant experience leading integration of Lean & Digital elements into key areas of Quality and Regulatory compliance. Other areas of significant expertise include:
– Quality System Governance: cGMPs, CFRs, and ICH guidelines, ensuring the highest standards of quality and compliance
– Simplification and Standardization: Implemented strategies to simplify and standardize systems, enhancing efficiency and reducing operational costs.
– Digital Transformation: Pioneered the use of digital change to drive organizational efficiency and foster agile ways of working
– Regulatory Inspection Management: Adept in owning and managing regulatory inspections, including FDA CBER and CDER, HPRA, and CFDA, ensuring compliance and success
– Proven skills in troubleshooting, decision-making, and project management to navigate complex challenges
– A mentor and coach, dedicated to unlocking the full potential of teams and individuals, ensuring peak performance
– Lean Principles Integration: Incorporated lean principles into both Quality Control and quality systems, driving continuous improvement
