Global Quality Assurance and Regulatory Compliance Expert

Expertise

• FDA and EU regulatory compliance.
• Global quality assurance in the pharmaceutical industry.
• GMP's - Good Manufacturing Practices.
• Quality systems, (CAPA, Corrective and Preventive Actions, change control, SOP's, and non-conformance investigations).
• 483's, warning letters and consent decree remediation.
• GMP's audits, due diligence audits, for cause audits, and mock PAI's audits.
• Process improvements.
• Project management.
• GAP assessments.
• Sterile products, aseptic process, system simulation tests, HEPA filters, water systems testing, dry and steam sterilization.
• Solid dosage, liquid semi-solids and transdermal patches products.
• Training and mentoring.
• Process and packaging validation - APR's, Automatic Packet Reporting System.
• Regulatory inspections preparation.
• Contract manufacturing management.
• Quality agreements development and maintenance.
• Batch documentation review, approval and product release.
• Support pharmaceutical projects from manufacturing and commercialization of sterile, liquid, semi-solids and transdermal products.
• Product complaint investigations, escort and redacting responses.

Experience

Undisclosed Company, Quality Account Manager, 2012 - 2014

• Lead teams and perform remediation in the different Quality Systems Elements (QSE), observations as part of the consent decree remediation organization and consent decree certification plan. This includes remediation as part of Hypercare Phase I (confirmation of QSE) and Hypercare phase II (certification of QSE).
• Completed a very complex quality agreement for a raw material supplier that met the confirmation and certification of a QSE as one important part of the CD remediation.
• Lead team of three internal manufacturing sites in major changes to improve the current contract service providers managing process.
• Oversaw, improved and developed environmental management quality systems to assured commitments with the CD plan and compliance with regulatory requirements.

Hospira Manufacturing, Quality Assurance Compliance Consultant, 2011 - 2012

• Responsible for the quality assurance and regulatory compliance of sterile injectable products produced through aseptic techniques by overseeing the manufacturing process.
• Managed and led the Warning Letters remediation efforts for regulatory compliance required.
• Coached and trained manufacturing and quality personnel in required cGMP's and required aseptic techniques.
• Led in reducing lag time in conducting proper deviation investigations and lowering the deviation occurrence rate through embedded QA expertise on the manufacturing floor.
• Project managed, the improvement and development of EM, (Environmental Management) quality systems to assured commitments with the CD plan and compliance with regulatory requirements.

Centocor, Quality Assurance Project Manager, 2011 - 2011

• Managed Quality Projects for this biotechnology company producing sterile and solid dosage products to assure compliance standards for U.S. and EU regulatory.
• Identified compliance GAPS and assured effective and on time mitigation. Requirements were continuously met.
• Assisted the inspection readiness team of the site in the preparation and execution of Regulatory Agencies Inspections.

Medimmune, (Astra Zeneca), Quality Assurance Specialist IV, 2010 - 2010

• Identified gaps and assured mitigation in Quality Systems and manufacturing processes through GMP audits in this company manufacturing sterile vaccines (Flumist).
• Assembled and evaluated manufacturing and QA data used to improve production-related processes.
• Utilized the QA Systems to assured compliance with cGMP regulations for production of sterile products.

Vectech Pharmaceutical Consulting International, Consultant, 2009 - 2010

• Applied expert knowledge of global cGMP's (FDA & EU), Quality Assurance and Regulatory Affairs to successfully achieve the manufacturing and market growth goals of global pharmaceutical companies producing sterile finished products and sterile API through aseptic process.
• Conducted cGMP audits and GAP assessments to identify, improve and correct necessary processes or systems.
• Assisted companies in their growth: assured success in regulatory inspections, designed SOPs to assure ongoing QA requirements are met; reviewed quality systems to identify and remedy gaps - created a "roadmap" for improvement and longer-term business success.

Global Pharmaceutical Supply Group, Quality Assurance External Manufacturing, 2000 - 2007

• Furthered expert skills in supply chain quality assurance of CMOs producing sterile products, solid dosage, liquids and semi-solids, which were located in North America, South America, Europe and Japan. This division of J&J was an approximately $10 billion global enterprise.
• Performed GMP, due diligence audits and mock PAI's; assured quality system standards such as product/process non-conformance investigations, CAPA, change control, process and packaging validation, etc. were in required regulatory compliance. Reviewed and approved documentation for final batch release.
• Assured compliance with all regulatory agencies (FDA/EU). As a member of GPSG License and Acquisition Team, performed due diligence for global companies which resulted in the expansion of the company's portfolio.
• Involved in product development process, process validation, cleaning validation, aseptic process simulation test, and packaging validation.
• Led QA process improvement projects, technology transfers and improvement of the manufacturing process. Developed and maintained quality agreements.
• Prepared numerous companies for the pre-approval Inspection - achieved a record of 1st pass inspection approvals for numerous J&J products.
• Proved expertise in rapid product launch: numerous key drug products were launched to market within 48 hours of FDA approvals - with no QA issues.

Janssen Pharmaceutical, Sr. Quality Assurance Associate, 1987 - 2000

• Markedly enhanced QA systems and controls for sterile products, solid dosage, liquids and semi solids products - established improved QA best practices; led affiliates and CMO's to record best compliance performances.
• Led transition to a lower volume - higher quality of supplier - which achieved better prices and quality and improved customer service. This longer-term supplier relationship became the operational standard.
• As part of the Global Drug Product Development Team, worked on 10 key new products through the entire product-development lifecycle, including: final qualification/validation, PAI's acceptance and commercial launch.
• Oversaw several CMO's and packaging material suppliers.

UpJohn Manufacturing Co., Quality Assurance Professional, 1979 - 1987

• Performed internal quality audits to sterile production, solid, liquids, and semi-solids areas.
• Developed and revised quality SOP's.
• Conducted annual product reviews.
• Performed non-conformance investigations.
• Performed CAPA responsibilities.
• Performed HEPA filter testing.
• Performed environmental monitoring.
• Conducted dry heat and steam sterilization validation.
• Reviewed and approved process and manufacturing validation.
• Managed supplier audits.

Honors & Publications

Credentials

Equipment and Systems Qualified

• Aseptic Sterile Process
• Dry Heat Ovens
• Steam Sterilizers
• Water System
• Media Fills (SST's)
• Quality Systems
• Non-Conformance Investigations
• Change Control
• CAPA
• SOP's,
• APR's

Licenses and Certifications

• Professional Engineer-P.E.
• Johnson & Johnson Certified Quality Auditor

Languages

• Spanish

Academic and Professional Affiliations

• Parenteral Drug Association - PDA
• American Society for Quality - ASQC
• International Society for Pharmaceutical Engineering - ISPE