Experienced/Progressive/Reliable Professional
OBJECTIVE: Management or consultation in Quality or Regulatory Affairs for a dynamic and progressive pharmaceutical or biotechnology company that wants to create and implement exemplary quality and compliance strategies.
PROFESSIONAL SUMMARY
I have enjoyed a productive career in the pharmaceutical industry and have selected and trained top-notch professional teams, developed quality and regulatory systems; planned, developed, and controlled quality strategies, built and managed laboratories and facilities commensurate with regulatory requirements and division and corporate goals, maintained product and process quality, ensured/assured regulatory compliance and product and company integrity in all relationships and problem solving opportunities. I am an innovative, experienced team builder and coach who has established excellent quality organizations and systems and who has a proven track record in successful completion of major projects requiring cross-functional cooperation at both division and plant sites. My expertise includes: Technology transfer from pilot plant to full-scale manufacturing; submission and defense of INDs, ANDAs, NDAs, 510Ks, 505Bs, and other CFR items with emphasis on CMC sections; development, implementation and final approval for quality and regulatory systems; management of documentation control center for SOPS, Master Batch Records, labeling and change control information and approval; strong knowledge of CAPA and risk management; final approval for product specifications and process parameters and final approval knowledge of OOS and other analytical and process problems and their resolution; selection, hiring and training of quality teams and the training of teams and manufacturing personnel (including top management) in TQM; planning and completion of internal and external audits; coordination and responsibility for regulatory inspections and responses.
William Stephen Holden: Experienced/Progressive/Reliable Professional
BSH, Inc.
1912 Carrbridge Way; Raleigh, North Carolina, 27615
(919) 847-4080
Cell phone: (919) 349-9914
E-mail: steveholden@nc.rr.com
E-Fax: (919) 595-7063
WORK HISTORY
Confidential Clients: International Pharmaceutical Corporations
Quality & Regulatory Consultant
· Provided Green Level procedure requirements (ISO Quality System) for a leading manufacturer of combination, implantable, medical devices to meet 21CFR Parts 210, 211 in addition to 21CFR Part 820 and others.
· Audited and provided microbiological and environmental control expertise for three laboratories, and associated manufacturing sites, for a major, non-sterile, solid dosage product, pharmaceutical company. Harmonized and standardized environmental practices for the entire company.
· Wrote and implemented three comprehensive Site Validation Master Programs/Plans.
· Co-wrote, with Engineering, a Site Utility Validation Master Plan
· Technical Advisor and Trainer for “Aseptic Process” and “Cleaning” Standard
· Practices.
· Co-wrote and implemented a site material clearance plan for product contact surfaces (elastomers and polymers). Developed vendor audit and performance documentation and procedures.
· Audited and recommended quality and process improvements in, Fractionation,
· Dissolving, and Filling, for controlling manufacturing operations. For example, I developed and implemented new methods for cleaning and decontaminating a key centrifugation process for blood serum fractionation.
· Technical advisor and coordinator of environmental and microbiological data acquisition for major mold litigation and process improvement purposes.
· Provided technical expertise and guidance for responses to CBER/CDER inspection observations.
· Technical advisor for solving media fill and aseptic processing problems.
· Reviewed, revised and certified the completeness and accuracy of validation documentation packages for clean rooms, freeze dryers, sterilizers, depyrogenation ovens and environmental control systems for a major producer of solid dosage and sterile lyophilized product.
· Recent experience with designing/outfitting new pharmaceutical plant and laboratories for manufacturing of traditional drugs in a clean environment and for producing and testing hormonal drugs and anti-cancer generic drugs in controlled environments.
MALLINCKRODT (TYCO) Saint Louis, Missouri
A multi-billion $/year manufacturer of sterile diagnostic imaging solutions, radiopharmaceuticals,therapeutic drugs and controlled substances for pain management and medical devices.
Quality Manager; Site Quality Manager; Quality and Regulatory Team Leader
· Built quality and regulatory team and coached 32 professionals in chemistry, microbiology, incoming quality control, records assurance (documentation, regulatory compliance and label control), product assurance, and process assurance (PAT). Assisted in hiring and training similar staff at manufacturing sites in Montreal, Mexico City and Dublin.
· Quality Regulatory Representative on the Strategic Planning Team for manufacturing and long range planning for the Imaging Division.
· Planned and administered expense budget of approximately $2M/year and blanket capital budget of $100K/year. Prepared and led project teams for capital/systems above $25K.
· Worked with customers, sales force and division management to satisfactorily resolve all quality and medical complaints and to report trends and to effect corrective action.
· Presented strategic and long-range quality plans and milestone results to division and corporate leaders.
· Division Quality Representative for company-wide national sales meetings for customer satisfaction issues and new product introductions.
· Established Quality Council, Quality Steering Committee and Quality Improvement Teams for Total Quality Management initiative, while reporting directly to the President of the Imaging Division. Lead Quality Cost teams on two separate occasions and under two different regimes.
· Responsible for good manufacturing practices (GMP), good laboratory practices ((GLP), and ISO standards at primary manufacturing sites and for all FDA, MCA, PDMA, EU, and DEA inspections and follows-ups.
· Led Quality Department through three plant expansions at Raleigh and assisted in the design and commissioning of sister plants in Mexico City and Montreal during expansion for $15 million in sales to $500+ million in sales and the number one position in sales of contrast media for use in cardiology and radiology. All facilities filled product in Class 100 clean rooms.
· Wrote or approved Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) validation protocols for all software and hardware used in manufacturing and control. Provided User Requirements and Functional Specifications for innovative Enterprise Resource Planning System for Operations.
· Developed chemistry, manufacturing and control (CMC) sections of all new drug applications for the Division through interaction with Regulatory Affairs and R&D at the corporate level and with the FDA locally and nationally. Prepared plant quality systems for pre-approval inspections and GMP inspections by the Food and Drug Administration and the Medicines Control Agency of the UK. Extensive and successful collaborative experience with CDER and CBER divisions of the FDA and their reviewing chemists and microbiologists. Answered quality complaints for devices and injectable liquids and provided data for IND and NDA adverse event reporting out of St. Louis for the Imaging Division.
· Designed, subcontracted, and operated walk-in stability storage facilities to meet US and ICH guidelines for sterile liquids in glass and semi-permeable containers.
· Key member of teams to introduce new products: Ioversol, Optiray, OptiMark, GastroMark, Albunex, and AngioMark and the revolutionary new pre-sterilized syringe delivery system, Ultraject. All injectable products were de facto aseptically filled and then terminally sterilized in an air-over-pressure steam autoclave.
· Developed CMC methods and information for alternate synthesis (Ioversol) API project that resulted in a $29 Million dollar cost reduction.
· Worked closely with other Mallinckrodt functions and vendors, nationally and internationally, to secure high quality components and raw materials at greatest value to the company and customer. As a result of the hands-on approach, I know and count as friends, many influential people in the supplier chain.
· Team Leader for Reengineering Implementation Team reporting to the Director of Site Operations. Determined through teamwork, the key steps for reengineering the Core Business Process and Operation Management Systems. Our team developed a workable sequence/schedule for implementation and metrics for performance through use of statistical analysis and progress charts for projects and processes. These were the fore-runners for Lean Manufacturing and Black Belt exercises.
Abbott Laboratories, Inc.
HPD
Rocky Mount, NC
Biological Quality Assurance Manager
· Steam and ETO sterilization, sterility testing, environmental control for aseptically filled and terminally sterilized products, animal testing and biological indicator/ antibiotic test and release. Key player in solving aseptic filling and product biological quality issues. Provided answers and improvements for two major FDA investigations and Warning Letter responses.
BECTON DICKINSON Franklin Lakes, New Jersey
Manufacturer of sterile medical devices and diagnostic equipment and materials
Microbiologist: Supervisor, Sterilization and Environmental Control; Manager, Biological Quality Assurance
· Began my career with BD as a “Traveling Microbiologist”: Trained US and International microbiologists and was an interim Chief Microbiologist for those who were sick, on leave, or on vacation, I acted as surrogate laboratory manager until key replacements could be hired and trained at various sites.
· Built and staffed environmental, tissue culture and sterility testing laboratories in California. I managed the in-house ethylene oxide sterilization facilities and the outsourcing of gamma radiation sterilization of devices for Falcon Plastics.
· Received extensive training in sterilization, packaging development, environmental research, clean room design, and practical application of quality principles in medical device manufacturing.
· Designed and monitored laminar flow molding operations for aseptic assembly of devices.
US ARMY BIOLOGICAL CENTER (a.k.a.) The Biological Warfare Center) Fort Detrick,
Frederick, Maryland
Biological Sciences Assistant (Pentagon Appointment
· Biohazard identification and control; propagation, purification and containment of viral and rickettsial microorganisms (Secret Clearance and extensive CBR training was required for this work).
US CENTER FOR DISEASE CONTROL (CDC), Atlanta, Georgia
Laboratory Aide
· Studies of endemic and epidemic viruses and vector control; biohazard training and control, and laboratory materials/supply/training.
EDUCATION AND TRAINING
· Undergraduate Degree-Biology, Chemistry/English University of North Alabama
· Advanced Microbiology Courses University of Maryland
· Scientific Management Courses/Computer Training North Carolina State Univ.
· Conversational Spanish UC Santa Barbara
· Weekend MBA Program Pepperdine University
I have completed numerous personal and management development courses and seminars from BD, Abbott and Mallinckrodt and other trade associations and subject matter experts. I am fortunate to have worked and trained under several recognized experts in their fields within the industry.
PROFESSIONAL ASSOCIATIONS AND PUBLICATIONS
American Society for Microbiology; American Society for Quality (Quality Management, Food & Drug) ; Parenteral Drug Association (Individual and Past Corporate Member), Past Chairman of Section 1113 Raleigh ASQ ; International Society of Pharmaceutical Engineers (ISPE); Institute of Environmental Sciences; North Carolina Pharmaceutical Discussion Group; Member of HIMA Steam Sterilization Development Group with Dr. Michael Korczynski; and the PMA Ampule Leak Detection Committee member for Dr. Joseph Swartz; Laminar Flow studies published in the American Association for Contamination Control magazine. Key member for establishing patents for pre-sterilized contrast media syringes for use in radiology imaging