Jody Lichaa

Offers global quality, compliance, and CMC strategies for real-world application. Focuses on developing and executing scalable and efficient quality solutions to meet business requirements including leading people and change.

Served as the strategic leader and operational manager to direct, oversee and manage all quality assurance activities. Drove the design, analysis and oversight of global, phase-appropriate Quality Management System (QMS) Structure to ensure compliance to applicable regulations, including U.S. and EU. Maintained ethical business practices and adherence to Novavax’s quality policies, ensuring deployment at all plant sites, and directed, oversaw and managed initiatives established for adherence to these quality policies at all levels of the organization. Directed, oversaw and managed the quality oversight of GxP activities (including SOP/policy development and maintenance, internal and external audit functions, clinical and planned commercial batch release program) to ensure patient safety and data integrity. Provided leadership, direction, and mentorship across all levels of the organization to assure quality assurance and validation strategies were known and implemented. Kept senior leadership apprised of changes to the quality compliance landscape affecting business performance. Supported lean initiatives and continuous improvement efforts, while maintaining highest level of quality. Developed and administered budgets, plans, and performance requirements linked to the quality assurance and validation departments. Hired, developed, and retained QA personnel (including contract staff) to create a high-performing credible team.

Managed Corporate QA/QC activities to support product development and manufacture of clinical trial material to US, Canadian, and EU GxP standards at this biodefense company. Included initial startup and implementation of a global QA Unit with facilities in US, Canada, and the UK. Managed a headcount of 21 through 3 managers/directors in the US, Canada, and the UK. Designed, implemented, and maintained quality systems to assure products were manufactured in compliance with GxPs. Critical quality systems included, but were not limited to, product release, deviation/nonconformance management, CAPA, change control, internal/external audits, documentation, and GxP training. Released product into clinic and nonclinical studies. Responsible for supplier quality management, including initial due diligence, qualification, quality agreement negotiation and execution, and on-going monitoring for compliance status verification. Management oversight of multiple subcontractor and partner locations in North America and Europe. Played a lead role in constructing CMC sections for FDA regulatory submissions and for USG contracts. Key player in preparation and hosting inspections/site visits.

Provided on-site quality leadership and expertise to strategic alliance partner, Avecia Biotechnology, in support of the development, manufacture and stockpile of a new generation recombinant protective antigen (rPA) anthrax vaccine for the US Government. Developed a quality infrastructure and core quality systems necessary for future EU and US licensure of the vaccine. System focus included: change control, batch record review, product release, complaints, recalls, deviation management/CAPA, labeling generation and approval, supplier quality, and document/data control. Participated in the hiring, mentorship, and development of new and existing staff to close infrastructure gaps.

Managed all quality/regulatory compliance needs for a 200+ employee plant including internal audits, supplier quality, and management of regulatory inspections. Expanded supplier quality responsibilities to include overall supplier quality program: audits, material notifications of change, supplier quality agreements. Supported day-to-day vaccines operations and product development. Responsible for department of 3, including 2 Compliance Auditors and 1 Supplier Quality Engineer. Additional responsibilities included also serving as Interim Quality Systems Manager from 04/2004-08/2004. During this time period, managed systems for CAPA, change control, exception management, and training. Responsible for 3 additional staff members, including 1 manager.

Entrusted to manage and influence vaccine plant’s quality and regulatory compliance needs during Global Compliance Manager’s short-term assignment away from plant, including advisory role to other departmental personnel. Managed the internal audit program in accordance to company, cGMP (US, EU, and Canadian) and GLP guidelines to include design and execution of yearly inspection schedule. Under minimal direction, increased execution of internal audits by 15% with 1 less audit team resource. Managed supplier quality audit program. Responsible for the management of regulatory and internal inspections from initiation to closure. Reported on status of all internal, external, and regulatory commitments to Sr. Management. Evaluated the adequacy and effectiveness of systemic deviations and corrective action system trends. Responsible for 1 headcount.

Responsible for the management of the supplier audit program including design, execution, and follow-up activities for suppliers at Corporate Headquarters of this pharmaceutical company. Designed and implemented the tracking and scheduling system for commercial marketed products annual product reviews. Developed and implemented cGMP education program that supported the company’s quality policies and current industry regulations.

Monitored non-clinical laboratory studies to assure compliance to GLP, ICH, and cGMP guidelines at this contract-testing firm. Reviewed and approved final reports and certificates of analyses for lot release, validation, and stability test articles according to established SOPs, protocols, and client technical specifications. Audited and inspected cGMP and ICH validation, qualification, and stability packages. Performed systems and phase inspections of all biomolecular assays. Conducted site audits of subcontractor facilities. Trained new employees and co-workers in cGMP guidelines.

Performed in process, finished, and stability testing on pharmaceutical products using multiple chemical techniques including HPLC, GC, and UV. Performed raw material testing in accordance to USP. Compiled, reviewed, and recommended disposition on all analytical laboratory results. Reviewed production batch records. Inspected and assisted in the release of multiple commercial products.

Performed in process, finished, and stability testing on monoclonal and polyclonal antibody and protein products using western blotting, purity gels, and gel electrophoresis. Reviewed test results from antibody and protein departments. Maintained sample retention storage.