Clare McDonnell
WORTHING
Summary
Accomplished Sterile Value Stream Director at GlaxoSmithKline Pharmaceuticals, with a proven track record in leading complex, high-value pharmaceutical projects to successful completion.
Expert in strategic planning, pharma operations management, and navigating MHRA requirements. Demonstrated ability to enhance team performance and collaboration, achieving significant operational improvements and compliance milestones.
Skilled in project management and quality systems, ensuring excellence in manufacturing and supply chain operations.
Results-driven leader with strong background in strategic management and organizational growth. Skilled in developing and implementing effective business strategies, optimizing processes, and driving team performance. Known for adaptability, effective collaboration, and delivering measurable outcomes in dynamic environments. Strong communication and problem-solving abilities, coupled with focus on fostering productive and positive team culture.
Overview
15
15
years of professional experience
Work History
Sterile Value Stream Director
GlaxoSmithKline Pharmaceuticals
10.2017 - 06.2020
- Responsible for all aspects of Manufacturing and Supply in Primary and Secondary operational manufacturing of Sterile antibiotics in an MHRA/FDA approved facility.
- Responsible of all aspects of Quality and EHS in Bulk Primary and Secondary facilities.
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
Senior Project Director
GlaxoSmithKline Pharmaceuticals
05.2015 - 10.2017
- Delivered a State of the Art £27m aseptic filling line though IQ,OQ,PQ to commercial supply. Managed a team of technical specialists to deliver a MHRA approved facility. Led a successful MHRA inspection and audit readiness process.
- Developed comprehensive project plans with clear financial and technical milestones, ensuring timely progress and measurable results.
- Utilized data-driven decision-making approaches to track project performance metrics and inform strategic adjustments as needed. Completed risk analysis of project deliverables and communicated as appropriate.
Transformation Director
GlaxoSmithKline Pharmaceuticals
01.2012 - 05.2015
- Site lead for the delivery of Quality &Compliance remediation programme and Site Restructuring
- Business Change process included the implementation of Site tiered accountability, Deviation and CAPA management process.
- Aligned departmental goals with overall company strategy, ensuring that individual efforts contributed directly to broader success.
- Conducted thorough analyses of existing processes, identifying opportunities for improvement and implementing necessary changes.
Parenterals Business Unit Leader
GlaxoSmithKline Pharmaceuticals
10.2005 - 01.2012
- Responsible for manufacture and supply of FDA/MHRA approved facilities to supply IV Augmentin, Amoxil and Timentin to worldwide markets.
- Established clear performance metrics, driving continuous improvement across all areas of the Business Unit.
- Championed quality assurance initiatives leading to enhanced product offerings and increased customer satisfaction ratings.
- Optimized resource allocation, maximizing return on investment and operational effectiveness.
Education
Bachelor of Science - Microbiology
Surrey University
Guildford, United Kingdom06-1987
Skills
- Strategic planning, delivery and of local objectives from GSK Pharma and Site objectives
- Pharma Operations management of highly complex regulated Sterile manufacturing facilities
- Extensive knowledge of GSK Quality systems, Validation, MHRA requirements, CAPA,Deviation management
- Project Management of complex, technical high value projects Risk analysis, Planning and delivery of milestones Communication to key stakeholders
Timeline
Sterile Value Stream Director
GlaxoSmithKline Pharmaceuticals
10.2017 - 06.2020
Senior Project Director
GlaxoSmithKline Pharmaceuticals
05.2015 - 10.2017
Transformation Director
GlaxoSmithKline Pharmaceuticals
01.2012 - 05.2015
Parenterals Business Unit Leader
GlaxoSmithKline Pharmaceuticals
10.2005 - 01.2012
Bachelor of Science - Microbiology
Surrey University
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