Biological-Clinical Manufacturing (Vaccines) Executive and Consultant

Expertise

• Biological and clinical manufacturing operations executive, providing a wide range of experience in quality leadership across many facets.
• Create, develop and recommend program and system changes pertaining to vaccine product release and deviation management resulting in more efficient product release to market and improved "right-first-time" manufacturing metric.
• Articulate leader with unparalleled work ethic coupled with a strong sense of urgency, keen interest and passion in making quality a key ingredient to the success of the corporation.

Focused Areas

• Auditing
• Control of Non-conforming Product
• Root Cause Analysis
• Microbiological Test Methods - Bioburden, TAMC, Sterility Testing
• Sterilization Methods - Steam, Gamma, Chemical, etc.
• Document Control and Data Analysis
• Supplier Management
• Management Review
• Microbiological Techniques
• Change Control
• Deviation Management
• Sterility Assurance
• Corrective and Preventative Action

Experience

ASA, T & Q C, LLC,  Owner and Principal, 2015 - Present

• This firm is focused on providing the pharmaceutical and biological industry with consulting services that help maximize quality systems and provide thorough training with regard to GxP compliance.
• Focus to; Maintaining regulatory compliance while minimizing compliance risks.
• Provide online training in the form of webinars to many organizations globally in the areas of :
• Quality systems compliance
• Webinar topics include
• Sterility Assurance
• Sterility Investigations
• CAPA implementation
• Non-conformance investigations
• Clean room Behavior
• Aseptic Technique
• Batch Record Review
• Autoclave Validation
• Sterilization methods and Environmental Monitoring

Musculoskeletal Transplant Foundation (MTF), Jessup, PA, 2015

Associate Director, Microbiology Laboratory and Quality Assurance

• As Associate Director for the nation's leading tissue bank, changes lives by connecting donors with surgeons and transplant recipients, responsible for:
• Management of MTF Microbiology Laboratories including personnel management and direction, sample tracking, workflow, data management, departmental planning, capital and expense budgeting and tracking of actual spending.
• Ensures testing performed by MTF's Microbiology Laboratories compliance with applicable government regulations, American Association of Tissue Banks' standards, applicable international regulations, and ISO 9001 and ISO 13485.
• Establishes the testing strategy and direction for the laboratories in the Jessup facility. Also acts as a contact for questions relating to testing and test methods with MTF's external testing partners.
• Developed, implemented and managed a Supplier Quality Management program.
• The Supplier Quality Management program is a partnership between Quality, Supply Chain and Regulatory with the Associate Director (MLSQM) taking the lead in the area of supplier quality including; leading the SQMT meeting and agenda, managing and resolving supplier issues through the SCAR program, supplier monitoring process and working with Regulatory on the Supplier audit program.

Johnson & Johnson, McNeil, Pharmaceuticals, Fort Washington, PA, 2013 - 2015

Quality Assurance Consultant

• As consultant for the American multinational medical device, pharmaceutical and consumer packaged goods manufacturer, assisted with consent decree remediation activities pertaining to site Quality Systems.
• Review and assessment of current procedures, processes, or practices for corporate-level QA/QC management oversight of the Covered Facilities; worked with McNeil senior and Covered Facilities' management to evaluate and address any observations by the cGMP expert regarding oversight procedures.
• Worked with the Enterprise Regulatory Compliance (ERC) group to develop procedures to monitor and verify corrective actions along with auditing the implementation and verification of corrective actions at the Covered Facilities.

Northeast Clinical Trials Group, Scranton, PA, Clinical Research Coordinator, 2012 - 2013

• GCP certified; Responsible for administrative aspects for Northeast Clinical Trials Group including contract negotiation, site management, billing, scheduling and staff management.
• Assisted with the investigational study selection and project negotiation, including initial site/sponsor correspondence, budget preparation, regulatory document preparations, source document preparation, informed consent and appropriate HIPPA inclusions for IRB submission; Ongoing management of study review process according to site, sponsor, and IRB guidelines, prepared and reviewed documents submitted to IRB.
• Reviewed protocols or study procedures and maintained a good working knowledge throughout the duration of a trial.
• Participated in conducting subject visits, which includes but is not limited to screening, inclusion/exclusion, and randomization of subjects.
• Maintained drug accountability and integrity.
• Created and maintained source documents. prepared for and participates in study visits with sponsors, monitors, and auditors throughout the duration of the trial.
• Conducted staff training with continued education prior to and during trials.
• Responsible for IRB approved Marketing for new trials as well as for NECTR as a corporation, completed case report forms in eCRF with experience in Inform 4.0 as well as Oracle.

Key Accomplishments

• Created, wrote, and established the site's core roles and responsibilities for a quality organization.
• Conducted training with medical staff on GCPs, Good documentation, FDA rules and regulations pertaining to Clinical Trials.
• Designed and implemented various systems to track quality indicators such as observations from Sponsor CRAs and CAPA plans.
• Led the High-Dose Influenza Clinical Trial management.
• Effectively reduced the number of audit observations coming from Sponsor CRA visits by implementing the use of Standard Operating Procedures and strengthening training of the staff.
• Enhanced customer service by implementing a system that tracks Serious Adverse Events, Follow-Up Appointments and Call Backs after medical visits.

Sanofi Pasteur, Swiftwater, PA, Quality Assurance Deputy Director, 2011 - 2012

• Oversaw the Formulation, Filling, Inspection, Packaging facilities for the largest company in the world devoted entirely to human vaccines.
• Reviewed incidents, CAPAs, audits for closure; review deviation investigations for appropriate root cause analysis, corrective action and evaluation.
• Performed timely review of SWIs, SOPs, and BPRs.
• Provided QA representation on FDA and corporate inspection teams.
• Responsible for FFIP compliance team and their respective development plans.
• Ensured timely closure of deviation investigations to support vaccine supply plan.

Key Accomplishments:

• Effectively built a Quality Assurance team around deviation management that reduced deviations from by 20%.
• Implemented a Shop-Floor team of individuals to maintain day-to-day activities on the manufacturing/filling operations areas.
• Successfully reduced and closed CAPA plans owned by the FFIP group by focusing individuals on the QA team on proper implementation and closure.
• Assisted with FDA 483 responses to observations found in the Inspection Department.

Director, Viral Process Team

• Orchestrated timely release of viral products to market; Interface between Industrial Operations and Commercial Operations for supply needs for the retail and healthcare markets pertaining to Fluzone and YF-VAX vaccine supply.
• Coordinated all activities of support groups to enable timely lot release.
• Generated weekly status reports on Fluzone production for the VP Marketing and President of Sanofi Pasteur.

Key Accomplishments

• Successfully released the Southern Hemisphere Influenza doses to the market within the established timelines despite multiple manufacturing challenges,
• Developed a system for tracking lot manufacture and release that allowed for real-time review of what stock was available for further processing.
• Re-established a cross-functional team, The Viral Product Team, which met weekly to review any challenges or new information concerning influenza production for that specific campaign.

Director, Quality Operations, Product Release

• Was appointed to direct site Product Release activities.
• Responsible for the management of the U.S. Batch Release team. And, for assisting in manufacturing investigations pertaining to product release.
• FDA SME on Product release. Responsible for the performance review and assessment of 20 direct reports; Interaction with Regulatory agencies.
• Timely compliant release of all licensed product, components and raw materials.

Key Accomplishments:

• Created, wrote and established the department's core ideology, purpose, core values and roles and responsibilities for a product release organization.
• Effectively hired, trained and organized a Product Release team comprised of over 30 individuals across product and raw material release groups.
• Developed a shop-floor Product Release initiative that successfully reduced Batch Record errors by 15%.
• Spearheaded the successful release of the 2010 H1N1 Influenza Pandemic campaign from a Product Release Perspective.
• Effectively managed the release of all doses of seasonal and pandemic vaccines to the market according to the tight timelines.
• Enhanced customer satisfaction by organizing headcount to be available on off-shifts to enable a swifter turn-around time for Batch Record closures.
• Successfully managed batch release turnaround time for 4 years at an average of 2 days.
• Successfully implemented many of the ideas/systems related to Flu Product Release while being the Quality Representative on the "Project Harmony" team.

Additional Professional Experience

Sanofi Pasteur, Swiftwater, PA, 2000 - 2008

• Deputy Director, Sterility Assurance
• Senior Compliance Official, QA,  2005 - 2006
• Aseptic Processing Manager, Sterility Assurance, 2004 - 2005
• Senior Compliance Official, QA, 2002 - 2004
• Senior Analytical Specialist, QC Micro/Sterility, 2002 - 2000

Lancaster Laboratories, Lancaster, PA

• Pharmaceutical Microbiologist, 2000

Honors & Publications

Publications

• Author and Co Author of publications in peer reviewed journals and educational text

Education

• B.S. Biology, Marywood University, Scranton, PA