SUMMARY OF EXPERIENCE

Corporate executive with over twenty-five years of experience in all aspects of cGMP facility, equipment and systems CGMP compliance, validation and project management. Experience has included both domestic and EU cGMPs. Areas of concentration have included bulk processes, containment, cosmetics, computer systems, fermentation (microbial and mammalian), blood products, aseptic processes and sterilization (ETO, E-Beam, Cobalt, steam). Consulted on the subjects of commissioning, validation and cGMP compliance to clients worldwide, including Europe, South Africa, South America, Japan, China and the Middle East. Extensive inspection and remediation experience with the FDA, locally and internationally, as well as with the EU. Addressed, managed, coordinated and remediated FDA and MHRA findings. Frequent lecturer on topics of validation, commissioning, regulatory initiatives and compliance to various industry organizations. Experienced QA Director in establishing specifications criteria OOS and product release. Experienced RA Director in establishing necessary programs for regulatory submissions, CAPA management, Complaint handling and adverse event reporting. Experienced manager of departments and people. Corporate Director for validation responsible for project management. Established standard practices for validation worldwide.

Consent Decree Remediation Project Management:

Warner Lambert, Schering Plough, Centeon, Abbot Medical, Genzyme, McNeil

Consent Decree Summary of Experience available upon request

MOST RECENT EXPERIENCE

Pharmaceutical cGMP Project Manager and cGMP Compliance Consultant (2011 to Present)

Johnson & Johnson (Global Engineering Senior Project Manager)

Consulting Senior Project Manager for Enterprise Liquids Platform

Using FPX techniques managed project milestones and work efforts for:

SME team development of liquids processing design tool

SME team for training initiatives

SME team for Cleanability pilot plant initiative

SME task force for standardized of specifications, URS, C&Q document templates

Alku Consulting (cGMP Compliance PM & Consultant)

Biotest Pharmaceuticals Compliance/Qualification/Validation Director

Consulting Project Director, for Qualification and Validation on a Warning Letter remediation endeavor. Staff of 8 direct reports in qualification and validation remediation strategy, activity and work effort.

Managing Quality System document and procedure reorganization as well as re-write

Successfully conducted site qualification and remediation assessment

Responsible for scheduling and project commitments

Oversight of protocol development and execution

Blood fractionation process equipment and clean utilities

Validant (cGMP Compliance PM & Consultant)

Assigned to McNeil Consent Decree as a site leader for facility technical transfer, qualification and validation. Responsibilities included site Quality Management System Element (QSE) leader for Technical Transfer C&Q, Process Development Qualification and Process Validation.

Managed preparation of remediation evidence binders

Site trainer for C&Q, Master Planning, PPQ, cleaning validation, packaging validation and CPV

Successfully Managed, formulated and completed audit observation responses

Managed tracking and metrics for audit observations and findings reports

Authored and edited various qualification and validation master plans and managed PPQ site readiness documentation with no observations

Reviewed, edited and authored multi-site network level SOPs

Managed and proctored verifier audits with minimal observation and recommendations

Quantic (cGMP Compliance PM & Consultant)

Assigned to Genzyme Consent Decree. Duties included Deviation investigation and CAPA remediation for facilities engineering and validation.

Organizing teams to perform necessary engineering, validation and QC Lab investigations.

Managed CAPA teams and remediation efforts for WFI and Clean Steam qualification and validation

Managed and formulated responses to FDA audit and verifier observations

Strategically managed solutions to improve utility sampling practices

MedImmune, Inc., Corporate Director Validation Quality Systems (2009 ---2011)

Responsibilities include management of corporate validation procedures, to provide consistent validation practices among all manufacturing sites. Quality Management System responsibilities as they applied to multi-site procedures, C&Q and validation.

Successfully implemented principles of QbD and removed silos of actions within product life cycle development.

Managed and implemented consistency of practice for proper corporate C&Q (commissioning and qualification) implementation consistent with ASTM-2500 and ISPE Guides.

Developed and implemented strategic plan for FDA Process Validation guide and EU Annex 15 regulations

Authored corporate QMS standards for validation and validation compliance metrics for use among the sites

Interfaced with and proctored regulatory inspections for EMEA, FDA, WHO and the Green Cross.

Successfully prepared and managed corporate responses to both FDA and MHRA.

Director and administrator for multi-site Operational Validation Council Committee

Participated as Corporate Director in the compliance and validation of H1N1 pandemic vaccine launch.

Authored and edited the development of CMC sections for PAS documentation for facility and product licensure.

Successfully lead MHRA validation and compliance CAPA remediation efforts for H1N1 vaccine production facility. Led root cause investigations and remediations.

Conducted overseas compliance audits for product supply chain (Mexico, China and Canada).

Successfully developed and implemented training program for moist heat sterilization.

Managed a multi-site team to implement EMEA EN285 expectations for moist heat sterilization. Resulted in the company being able to successfully market to the EU

Successfully managed task force teams to implement GAMP 5 and EU Annex 1 requirements.

Inverness Medical Innovations, Sr. Director Quality Systems and Regulatory Affairs (2007 – 2009)

Responsible for the generic drug program in conjunction with existing nutritional and OTC production/product portfolio.

Over saw the financial planning and engineering design for a multi-million dollar generic facility construction

Successfully acquired, managed and launched two prescription drug ANDAs

Regulatory Affairs Director and submitted FDA ANDA supplement notifications

Initiated and completed two plant-wide QMS assessments.

Led a structured team to develop and initiate CAPA, vendor certification and Change Control as part of QMS

Point of contact for FDA and regulatory (DEA) audits with minor observations

Responsible contact person within the company for Quality and regulatory issues

Managed a staff of ten dealing with various foreign country regulatory submissions and QC lab operations

Managed the auditing of internal operations as well as vendor suppliers

Oversaw batch release, review and investigations

Developed metrics for quality management showing deficiency remediation, OOS, CAPA and complaint status

Bristol-Myers Squibb Company, Associate Director Quality Assurance (2005 – 2007)

Management, coordination and review of Multi-site validation and facility compliance activities. Provided consultation, guidance and review of all engineering projects associated with R&D, API, BioTech, clinical manufacturing.

Responsible for new Policy initiatives, QMS QA SOP development and facility qualification

documentation review and approval. (SOPs, IQ, OQ, PQ, SATs FATs, VMPs, change control, investigations and CAPA)

Supervised 8 departmental personnel, as well as consultation and recommendations for FDA and EU compliance

Responsible for consistent cGMP, Qualification and application of best practices for manufacture of drug and clinical

QA responsibilities for sterile manufacturing, Containment, API, scale up, CSV, utilities and commissioned systems.

Authored SVMP and SMF for MHRA (EU) certification. This resulted in no critical observations for EU licensing.

Managed Change Control Program and standardized change control management. Successfully formed Validation leadership team for qualification/validation and multi-site harmonization

Aker Kvaerner Pharmaceuticals, Vice President Compliance Services (2003 - 2005)

Responsible for the management and coordination of cGMP consultation and validation activities. Also responsible for proposals, project progress, client relations, staffing and presentation of teams as well as maintaining budgets

Provided cGMP and validation consultation as well as training to domestic & overseas clients

Coordinated worldwide validation activities with affiliates in Europe and Asia.

Provided consultation and project management on a variety of filling line related

equipment, tablet presses, capsule fillers, liquid fill, vial fill and aseptic operations.

Managed containment validation (steroid, potent compounds isolator technology)

Managed and participated in the Astra Zeneca Part 11 remediation project

Managed aspects of engineering and validation projects of + $50MM

Company closed NE operations

Foster Wheeler USA. Corporation Director of Validation/Compliance, Worldwide (1997 – 2003)

Provided consultation and reviews to overseas clients. Participated in developing marketing strategies, business management and forecasting for validation and integrated engineering and validation projects. Coordinated and developed proposals as well as sales and marketing presentations. Developed internal project costing and tracking to better control engineering and validation work load as well as enable accurate forecasting. Provided training as necessary.

Managed all and related validation and qualification projects

Worked extensively with affiliate offices around the world

Managed a department of 50 individuals with varying projects assignments

Managed and consulted on aspects of Abbot consent decree

Managed and participated in the PSGA and GSK Part 11 remediation project

Managed Merck MSO equipment and CSV C&Q and validation efforts

Responsible for department budgets and projects as applicable. A Y2K project $8MM for the company

Centeon Consent decree remediation management and consultation

Schering Plough Consent decree remediation management and consultation

Company closed US pharmaceutical operations

Prior Experience (pre-1997)

Medical device design, engineering validation project management

Medical device 510K and PMA successful submissions

Warner Lambert Consent Decree

Medical Device Summary of Experience available upon request

EDUCATION, AFFILIATIONS & CERFICATIONS

MSE Engineering Management, Drexel University

MSE Biomedical Engineering, University of Pennsylvania

BS Biology, Ursinus College

Member: ISPE, PDA, ASQ, IVT, PMI, GCP

Board of Directors IVT

Industry Advisory Board Stevens Institute of Technology

Active participant with ISPE Pharmaceutical Guide committees

ASQ Section 505 (Philadelphia) Education Chair Person

CFPA Instructor (RCA and CAPA, cGMP Certification)

ASQ Instructor (CQA, CQE)

Past adjunct Professor for:

oTemple University

oStevens Institute of Technology

Certifications

PMI - PMP

ASQ - CQE

ASQ - CQA

ASQ - CPGP

J&J - FPX

PRESENTATIONS

Frequent speaker to organizations such as ISPE, PDA, IVT, IIR, DIA, PDA and The Center for Professional Development.

PUBLICATIONS

Published author of numerous articles on the subjects of cGMP compliance, automation, commissioning and validation (available upon request).

Participant and contributing author with two ISPE Base Line Guides

API Baseline Guide, Volume 1

Commissioning and Qualification Baseline Guide, Volume 5

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