INDUSTRY CONSULTANT 2017 – Present
Providing Practical Compliance services for companies regulated by the US FDA, ISO 13485:2016, and EU MDR and Health Authority regulations from State to Global. Clients range from start up to Fortune 500 companies, resulting in robust Quality Systems with significantly improved FDA compliance outcomes tailored to your business.
Recent contracts include:
- EUA PPE Class II Medical Device – Assessment of Design Controls for EUA registration with US FDA.
- Drug/Device Combination Product – US FDA Warning Letter/483 Remediation – Production & Process Controls Remediation Lead - (Inspection & Test / Validation / Data Integrity / Knowledge Transfer process)
- Pharma / Medical Device - Remote Audits Asia (India, Singapore, South Korea)
- OTC Drug – CMC Compliance assessments for a successful new product launch
- South Korea API – On site Quality Systems GMP Consultant. Remediated Quality Systems SOPs to meet US FDA regulations. Developed training materials and trained staff in GMPs across the product development and manufacturing lifecycle, such as Batch records, Data Integrity, OOS/OOT, TMV/ TM Transfer and CAPA / Deviation Management. Conducted workshops on Quality Risk Management (QRM) and Root Cause Analysis on real life issues to improve compliance understanding and documentation of records.
- Fortune 500 Pharmaceutical – Project Manager. Oversight and project management for the revision and development of global procedures working with SMEs globally
- California Cannabis Start Up – Developed GMPs and Quality System to meet new CA regulations. Business met goals to achieve license for manufacturing of cannabis goods.
JOHNSON & JOHNSON
J&J Cardiovascular and Specialty Systems (Acclarent/Biosense Webster/Advanced Sterilization Products/Sterilmed) Irvine, CA
SENIOR DIRECTOR, QUALITY SYSTEMS – MEDICAL DEVICE 2015 – 2017
Led GMP Quality Systems integration and remediation for J&J Medical Device companies for both newly acquired and legacy companies. Spearheaded multi-year parallel Quality Systems remediation projects to meet new Corporate and ISO 13485:2016 requirements that met all milestones on time and on budget. Achieved Quality Systems integration of new company acquisitions and alignment of legacy companies to corporate policies and objectives.
- Led J&J cross sector (Medical Device, Consumer, Pharma) global teams to develop harmonized corporate wide SOPs that reduced complexity and improved cross company integration, resulting in efficiency gains in Procurement processes.
- Developed and facilitated cross functional Quality System training workshops to successfully implement new processes
- Purchasing Controls, Deviation, CAPA and complaint remediation
J&J Enterprise Quality Systems, New Brunswick, NJ
Provided key strategic direction and oversight for the Quality Management System within J&J Consumer Healthcare to ensure simplification, standardization, and optimization of Segment quality systems in alignment with J&J QS vision and strategy. Accountable for global deployment of Enterprise standards to all units within Consumer Healthcare. Owner of all global metrics and reporting analytics for data driven improvement across all regions.
SENIOR DIRECTOR, CORPORATE QUALITY SYSTEMS 2013 – 2015
- Led global deployment of Enterprise Quality Standards across all Consumer Health J&J Companies, to simplify and harmonize quality processes across 34 Quality System Elements.
- Developed and implemented infrastructure for effective global communication across functions and regions, providing forums for effective change management.
J&J Consumer Health, Skillman, NJ
SENIOR DIRECTOR, CONSUMER HEALTHCARE QUALITY SYSTEMS 2011 – 2013
Global governance and ownership of the J&J Consumer Healthcare Quality System (QS), including QS Programs and Processes; Training; CAPA / Deviation Management, Complaint Vigilance, Change Control; global R&D processes; QS Business Ownership of QS technologies. J&J Consumer Companies representative on J&J Corporate Enterprise QS Leadership Team.
- Harmonized SOPs across all J&J Consumer Healthcare Companies globally.
- Created global Centers of Excellence for Clinical Trials, Complaint Vigilance, CAPA, Document Management, Deviation Management, Change Control, Training, Metrics and Project Management.
- Developed and deployed Corporate wide Quality Policy Standards as part of the Cross Sector Enterprise Quality Systems Team.
Neutrogena Corporation (a Johnson & Johnson company), Los Angeles, CA
HEAD OF QUALITY 2007 – 2011
Board level, Head of Quality for internal and external manufacturing, new product realization to customer satisfaction.
- Led multiple successful FDA Audits as Management Representative ensuring regulatory compliance.
- Implemented monthly Management Reviews at Board level ensuring proactive board buy-in.
- Designed and Built facilities, laboratories and processes to meet changing requirements for OTC drug facilities.
ADDITIONAL CAREER HIGHLIGHTS (1990 – 2007)
Director Quality Engineering, Supplier Management, Manager of Analytical Chemistry and Microbiology Laboratories, Head of Operations at J&J UK Manufacturing facility, Quality Control Manager at Estee Lauder UK, SAP Implementation Change Management Lead
EDUCATION / PROFESSIONAL DEVELOPMENT
Bachelor of Science, Industrial Chemistry, University of Limerick, Ireland
Statistical Quality Control, London UK City & Guilds Certificate
APICS CPIM US, Basics of Supply Chain Management
BSI Auditor – ISO 13485 Medical Device Standard