Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Professional with over 30 years of solid technical and compliance knowledge in manufacturing, operations, and technical management. Experience working in top global medical device, drug, biologics, and combination product manufacturing companies. Background in intraocular lenses, drug eluding stents, coated stents, ointments, capsules, tablets, crèmes, vitamins, nutritionals, diagnostics, veterinary injectables, cosmetics, etc.

CORE COMPETENCIES

  • Equipment Design and Selection
  • Product and Process Line Start-ups
  • Pharmaceutical Transfers and Start-ups
  • Medical Device Start-ups
  • Sterile Production and Sterilization
  • Clean Rooms
  • Aseptic Techniques
  • Commissioning and Decommissioning
  • 21 CFR Parts 4/210/211/820
  • ISO 13485/9001
  • Deviation and Change Controls
  • Project Management/Leadership
  • Re-Design Processes
  • New Product Transfers
  • Water Systems
  • FDA 483 Items
  • Warning Letter Remediation
  • Process Validation
  • Corrective and Preventative Action
  • Six Sigma and Process Excellence

SELECTED ACCOMPLISHMENTS

  • Project managed major combination drug/medical device manufacturer of new product, including:
    • Supported manufacture of drug-eluting stent.
    • Served as project management steering committee member as liaison and mentor to team in pharmaceutical regulations and compliance.
    • Addressed critical FDA 483 items and warning letter remediation process / activities.
    • Received considerable recognition for identification and resolution of business issues.
  • Project managed movement of operations for major North American pharmaceutical parenteral facility, including:
    • Moved injectable facility from Ft. Washington to new site.
    • Worked with R&D in development, scaled up and transferred new products including ESPREX, Alfenta, Sufenta, Haldol Dec, Haldol Injection, and Levaquin.
    • Managed budget in excess of $30MM and secured FDA approval.
    • Managed first approved biotech facility and product (Regranex Ointment) by CBER outside continental USA with $18MM project cost and secured FDA approval.
    • Directed operations (Pharmaceutical Products) and created new products support structure for management and engineering.
    • Supported activities in process transfers, facilities commissioning, validations, and startup of processes after FDA approval.
    • Provided leadership / liaison for startup of (coated stent) in San German.
    • Provided leadership to transfer of domestic and international (Europe, Mexico and Puerto Rico) high profile products.
    • Maintained business continuity (in addition to increased efficiencies) which was recognized as significant contribution resulting in formal corporate recognition.
  • Managed numerous projects for major pharmaceutical manufacturer responsible for all financial, regulatory, compliance, knowledge transfer, audit readiness and key technical activities, including:
    • Managed blow fill and seal process expansion from one line to 12.
    • Created 250 new jobs and met $35MM budget with FDA approval.
    • Managed cost reduction project to improve capsules and compression process.
    • Reduced nonvalue-added head count, replaced equipment and increased efficiency by more than 60%.
    • Closed facility in San Lorenzo Puerto Rico and transferred intraocular lenses operation process to new facility responsible for $20MM budget, receiving FDA approval.
    • Managed commissioning and validation of all processes with $32MM project scope (injectable, tablets, and crème).
    • Led over 600 associates focused on manufacture of pharmaceutical and ophthalmic products which included Eprex (erythropoietin), Levaquin, Reopro, Regranex, Leustatin, Alfenta, Cypher Stent).
  • Managed major pharmaceutical facility (infrastructure and facilities) that was not in production, but needed to be kept operational consisting of more than 400K square feet of area distributed in seven (7) buildings and 70 acres of land – Maintenance cost reduction assignment.
  • Performed remediation work for major multinational pharmaceutical company, including:
    • Reviewed and performed investigations related to complaints, deviations and change control, driven by previous FDA 483 observations and agreed actions with the agency.
    • Responsible for parallel project to develop a sustainable complaints investigations system.
    • Conducted fault tree analysis of manufacturing processes.
    • Mentored management towards an audit readiness process.
  • Completed 7 months readiness preparation for Dominican Republic medical device company for corporate audit and a remediation phase, including:
    • Focused readiness process towards building maintenance, preventive maintenance program and housekeeping, site training program, master validation, and site master plan.
    • Set up audit war room, audit rehearsals, and mentoring to SME.
    • Facilitated change controls review and updates, critical complaints investigations, CAPA needs and mentoring of the staff in the investigations approach from a regulatory and compliance perspective.
  • Managed and consulted for various projects for pharmaceutical and medical device manufacturers, including:
    • Provided consulting services as agent to foreign pharmaceutical company in Caracas, Venezuela coordinating and guiding their new product development.
    • Provided regulatory consulting for Puerto Rican pharmaceutical company manufacturing private label pharmaceuticals.
    • Provided regulatory consulting for product development of nutritional supplements for Miami based manufacturer.
    • Provided consulting support for outsourcing needs for German manufacturer of physiotherapy systems, innovative cardiology products, diagnostic products and software.
    • Designed and selected equipment for start-up new product/processes line and facility for pharmaceutical and medical device.
    • Led cross-functional team as operations director for new product transfers
    • Identified/implemented major process improvement to enhance product quality with automation and re-designed process.
    • Controlled sterile production (clean rooms, aseptic techniques, sterilization, water systems, purified water USP via mixed beds, reverse osmosis, distillation WFI, HVAC, product inspections of ampoules, vials, and devices).
    • Supervised validation department in all technical/validations activities at site.
  • Managed new products transfer, directed operations (Pharmaceutical Products) created new products support structure for management and engineering of major pharmaceutical manufacturer.
    • Products transferred to Puerto Rico were Eprex, Levaquin, Leustatin, Alfenta.
    • Responsible for the support activities in process transfers, facilities commissioning, validations and the startup of processes after FDA approval.
    • Provided leadership / liaison for the startup of (coated stent) in San German.
    • Provided leadership to transfer of domestic and international (Europe, Mexico and Puerto Rico) high profile products. Maintained business continuity (in addition to increased efficiencies) which was recognized by as a significant contribution resulting in formal corporate recognition.

PROFESSIONAL EXPERIENCE

  • Dario Olivera Consulting, Inc. President, (Mayaguez, Puerto Rico) – 2007 to Present
  • Cordis, LLC (Combo Products), Technical Transfer Manager – 2004 to 2007
  • Ortho McNeil Janssen Pharmaceuticals, Inc. Director Operations – 1987 to 2004
  • Cooper Labs / IOLAB (J&J), Inc. (Sterile Opthalmic), Operations Manager – 1982 to 1987
  • Merck, Process Head (Barceloneta, PR) – 1981 to 1982
  • Dade Diagnostics, Section Head (Aguada, PR.) – 1976 to 1981
  • Carter Pharmaceutical, Microbiologist (Rincon, PR) – 1975 to 1976

EDUCATION

  • Executive Education Program, Fuqua School of Business, Duke University – 1997
  • Bachelor of Science, Biology/Chemistry, University of Puerto Rico – 1972

CERTIFICATION

  • Project Management, ISPE – 2000
  • Process Excellence, J&J – 1999
  • Certified Quality Systems Trainer, J&J – 1995