Consulting services for a wide range of GxP activities related to pharmaceutical drug manufacturing and GxP compliance. Specializing in development, implementation and improvements to Quality Management Systems. Experience with cell therapy and gene therapy products.•Skills include: Quality Systems and Quality Operations. Deviations/CAPAs, Product Complaints, Validation, Product Lot Release, Material Release, NCMR, Document Control, Audit Program, Equipment Programs (calibration, validation and OOT) and Change Control.•Experienced in hiring/training and managing QA staff, budget preparation, aseptic processing, sterile gowning programs, EM Programs, supplier qualification and supplier notifications, validated computerized systems, Quality Agreements, EDMS/LIMS implementations, tech transfer projects and managing Contract Service Providers.

Imvax is an early clinical stage biotechnology company focused on the development of novel autologous immunotherapies for the treatment of solid tumors. Responsibilities included oversight of 2 CMOs, Quality Lead for tech transfer to a new CDMO, participation in design and build out of a new manufacturing facility for Imvax, implementation of a new EDMS and development of the QMS for Imvax. This role included participation in the CMC meetings, developing a staffing plan for a rapidly developing business strategy and authoring SOPs for the QA/QC function.

Site Head of Quality – Lonza Houston, TX (05/18 – 04/19)Lonza Houston is a CDMO focused on Cell and Gene Therapy (C>) products. Served as the Quality Organization Head which included QA Operations, Quality Systems, Quality Control, Validation, and Sterility Assurance. The Quality organization was comprised of 70-80 FTEs and 20-40 contractors. This position included oversight of facility start up activities for Lonza’s Center of Excellence for Cell and Gene Therapy in Houston, TX. Support of client audits as well as Corporate audits was a routine responsibility. The site was in a period of rapid growth and restructuring to align with a new corporate vision requiring high levels of flexibility and leading the team through a difficult transitional period. Responsibilities included budgets, staffing, SLT participation, strategic quality planning, preparation for first site PAI, and problem solving related to compliance for GXP areas.Head of QA - Cell Therapy in Walkersville, MD (01/18 – 05/18)Lonza Walkersville is a multi-product site that also supports Media and LAL Test Kit manufacturing. Walkersville included a Cell Therapy CDMO division comprised of 150-200 staff members. Lonza relocated all C> operations to Houston, TX and Portsmouth, NH in 2018 which led to my relocation to Houston, Texas. This position was Head of Quality Operations for the cell therapy manufacturing facility and included management of 12-15 Quality staff. Responsibilities included supporting client audits and requests, responding to requests from Corporate, participating in response to audit/inspection observations, budgets, staffing and leading problem solving initiatives for the Cell Therapy Operations team.

Consulting for the Pharmaceutical Industry specializing in Quality Management Systems•Consulting services for a wide range of GMP activities related to pharmaceutical drug manufacturing. Specializing in development, implementation and improvements to Quality Management Systems. •Skills include the following: Deviations/CAPAs, Product Complaints, Validation, Lot Release, , Material Release/NCMR, Document Control, Audit Program/Supplier Qualification, Equipment Programs (calibration, validation and OOT) and Change Control.•Experienced in hiring/training and managing QA staff, budget preparation, aseptic processing, gowning programs, EM Programs, managing supplier notifications, validated computer systems, Quality Agreements, EDMS/LIMS implementations, tech transfer projects and managing CMOs.

Head of QA Department for a cell therapy manufacturing facility (Phase I/II). Responsible for strategic quality direction, improvements to all Quality Systems and oversight of clinical product manufacturing, testing and release activities. Responsibilities included budgets, staffing, quality lead for tech transfer projects, and problem solving for GXP areas. Led the Director’s Team meetings and wrote or revised all QA SOPs. Key participant in improvements to the material program, equipment program, stability program, and EM program.Note: Initially provided consulting services - transitioned to FTE in July

Consulting for the Pharmaceutical Industry specializing in Quality Management Systems-management of QA functions including Deviations, Supplier Qualification/Audit Program, Lot Release, Change Control, Annual Product Review, Validation, Equipment Programs, Document Control, Stability and validated Computer Systems-development and implementation of quality systems-improvement of existing quality systems-tech transfer projects-management of quality system-leadership of special projects

Prometheus was a small pharmaceutical company focused on gastrointestinal conditions. The site provided clinical diagnostic services and oversight for several virtually manufactured commercial pharmaceutical products. Responsibilities included QA support for the diagnostics laboratory located on site at the San Diego facility as well as Quality oversight for several Contract Service Providers. Activities under my supervision included change control, annual reports, deviations/CAPAs, supplier complaints, product release and product labeling. Supported material release and validated computerized systems. Developed the program for managing computerized systems in the diagnostics laboratory.Note: Initially provided consulting services beginning Oct 2008 - transitioned to FTE in February 2009.

Managed the QMS for a small virtual manufacturing start up. Products included a biologic drug and a topical cream for infection. Also had responsibility for qualifying and managing the EDMS. Managed the QMS programs and wrote SOPs for multiple departments.

Senior Associate - Corporate Quality Computer Validation (3/05 – 09/05)Provided Quality oversight of validation activities for several global and/or site validated computerized systems.Senior Associate - Corporate Quality Assurance (05/04 – 03/05)Participated in project to develop Enterprise Wide Multi-Site Change Control Practice. Managed Change Control system supporting validated IT systems for the West Coast.Senior Associate - QA, Change Control (12/02 – 05/04)Developed and implemented a new site Change Control system. Evaluated and managed GMP changes including facilities, utilities, equipment, documents, process, materials, QC instrumentation, and contract sites.

Quality Assurance Associate - Agouron Pharmaceuticals / Pfizer (11/97 – 8/00)Pfizer purchased Agouron Pharmaceuticals which was a start up focused on developing combinatorial libraries for small molecule drugs. Responsibilities: Key participant in development of a site change control program. Provided Contract Site management which included implementation of standards and procedures to ensure compliance. Created a system of QA Manuals that represented the core requirements for each contract site.Stability Coordinator, Manufacturing Planning (2/96 – 11/97)Managed the testing and collection of data obtained for stability samples of Marketed Products.Developed and prepared stability protocols and approved change controls related to stability impact. Authored the stability section of the IND submission.Administrative Assistant, Scientific Research and Development (08/94 – 02/96)Provided administrative support for the Director of Scientific Research and team of research scientists.