Gary U.

Provide oversight of the Acquisition of Xellia Pharmaceuticals by Hikma for sites specific to Ohio, USA and Zagreb Croatia. Manage the transition of GMP required Applications and Systems including all Data extractions to facilitate a network and product ownership transfer per cGMP Part 11 for electronic Systems, and CFR 314.82 Transfer or property ownership of pharmaceutical drug products. • Facilitate tracking, progress and Licensing of 59 total Applications. • Gather and coordinate the extraction of historical data from such systems as Trackwise DVCS, Success Factors, Novatek EM, Empower, Amplexor MyProcess and Minitab. • Gather licensing and requirements for the above referenced applications. • Obtain quotes and services from Veeva One Quality Systems for the implementation of 5 modules (DMS, Deviation, Change Control, LIR, and CAPA) • Obtain license cost quotes by working directly with software vendors. • Implement Veeva Quality One Suite and Veeva Document Management systems. • Coordinate the need and hiring of external IT personnel to perform extraction of data. • Provide Stakeholder Project updates weekly with the VP of IT, GMP QA, Legal and Compliance • Facilitate discussion topics that arise out of scope creep on the project. • Prepare Purchase Order Requests as needed. • Draft, review, or approve migration plans as required to validate the extraction and migration of critical cGMP data.

Provide consulting services for the management of the Post Market Surveillance program. Supervise staff of 7 investigators, and 3 researchers. Multi-Site Management (Allentown, and Philadelphia Suburbs) Provide administrative support through Veeva Quality One Systems. Front facing customer interaction to resolve issues and roadblocks. Provide team support for customer and regulatory audits. Conduct team strategy and skill building initiatives for further development.

Perform specific duties as designed via agreement between Client and Oxford including services as a Project Manager, Senior Business Analyst, eQMS Implementation engineer, and Technical Writer for various Life Science clients under FDA regulations.

Providing training and other GMP Quality part-time consulting services for Class 1 Medical Device Manufacturer in preparation for FDA compliance audit. Services include: • Inspection Readiness to prepare facility for first FDA Compliance audit. Including, training of employees on the process, performing a mock audit with staff and stake holders, offering guidance on best practices to help alleviate stress and roadblocks. • Implementation of fully compliant CFR 820 Quality System including, Non-Conformance, Deviation, CAPA, Change Management, Supplier Quality Approval, SCAR, Complaint and Recall processes and Procedures. • Provide 1 on 1 coaching and mentoring with each staff member to help alleviate the stress and anxiety with the vast changes taking place in the environment. • Holding weekly team meetings to elicit feedback (Good and bad) on how the changes are affecting productivity and day to day business operations and providing support service to help staff and personnel adjust to the new Quality System changes. • Ground Up Constructions of 250+ New Quality Controlled SOPs, WI’s, FORMS, Policies and governance documents. • Preparation and simulation of FDA audit Readiness with a steady growth of improvement in reaction time, document readiness,

Provide guidance and expertise on various Quality System Projects for clients in the Life Sciences space. Including large projects for implementation of GMP Quality Systems, Electronic Quality Systems, Change Management, Consent Decree Remediation and Change Management. • Member of implementation teams for eQMS projects including (Veeva, Documentum, Open Text, LMS systems) • Development of Junior associates within the organization • Scripting for demonstration strategies (Use Cases, UAT Scripts) • Configuration services for implementation projections • Team Leadership for junior associates within the given team structure based on Project needs • Business Development Activities as needed or required • Development of process changes and oversight of Change • Lead Change Management Activities based on project needs • Budget Management for projects ranging from $500k to $5 million • Provide professional consulting services on FDA regulation, process improvement, budget development, system development and personnel development.

Providing both Full-Time and Consulting Services for the following organizations: Oncolytics Biotech Inc. 02/2017-04/2018 (Quality Systems Implementation) Immunomedics Inc. 08/2017 – 11/2017 – (GxP Quality Systems Implementation Manager including Clinical Trials) Pfizer, Inc. 05/2017-08/2017 – Process Quality Manager Consultant Philips Healthcare (Medical Systems via Life Sciences) 05/2015 – 10/2015 (Senior PTC Windchill Process Owner) Teva Pharmaceutical 09/2015 -05/2017 (Supplier Quality Manager) Zimmer Inc., 01/2015 – 05/2015 (Business Process Manager for Trackwise DVCS Implementation) McNeil Consumer Healthcare. 10/2012 – 12/2013 (System Administrator/Implementation Manager for ETQ) Depuy Synthes 2/2014 -12/2014 (Recall investigation Engineer, Lead) Onconova Therapeutics 02/2013-10/2013 (Acting Director of Quality Assurance) Custom Ultrasonics 7-2012-12/2012 – Consent Decree Remediation Director Hershey Foods 01/2012 – 07/2012 (GMP Quality Start-up Engineer) PharmAthene, Inc. 08/2011-01/2012 (Senior Quality Engineer CMO Supply Chain) USAMMDA (Div. of USAMRID) 02/2011 – 08/2011 (Contract Quality Engineer) Foster relationships with C-Suite leaders to consult on cGxP quality designs, change approvals, site audits, and compliance requirements that align with corporate goals. Oversight of Consent Decree Remediation. Mentor and train team members to design project deliverables including the statement of work (SOW), work breakdown structures (WBS), status reports, process maps, and business continuity (BCP) action plans. Perform gap analyses, incident investigations using Method 1 (M1) workflows, and root cause analyses for process failures. Enforce cGxP compliance using various methods and tools. Evaluate current eQMS solutions within clients QMS realm, develop user requirements for eQMS upgrades. Conduct training of personnel on the methods of HHE field investigations, CAPA Triage and Quality System flow.

Clinical and Commercial Biologic manufacturer based out of Gaithersburg, MD, specializing in Phase I-III Clinical drug manufacturing, release and trails. Team member for the $250 million-dollar Pilot Facility design, flow and compliance program. eQMS Superuser and implementation volunteer for Trackwise DVCS, Aegis Document Management System, and SharePoint implementation. Selected Project Accomplishments:  Perform facility audits on a monthly basis determined by pre-define schedule.  Evaluate and monitor Aseptic processing areas  Perform Nonconformance investigations and moderate CAPA programs  Serve as a member of the internal QRB and CRB.  Perform essential QA on the floor/Compliance on the floor facility inspections of Lab and Manufacturing Areas.  Evaluated failures of change control remedies. (McNeil)  Determined deviation impacts on manufacturing processes during triage and disposed of quarantined materials.  Address findings within FDA issued Warning letters and/or Consent Decree Obligations.  Used ADDIE techniques to introduce training programs in SOPs, auditing, and other multi-use quality system programs and processes.  Implement Quality by Design Principles  Lead remediation activities for CAPA Programs, and Manufacturing Non-conformances  De-commission of original licensed facility located @Watkins Mill Rd in Gaithersburg.  Assist process engineering with the commissioning of the 6 floor, 300,000 sq ft. Pilot facility built in 2006.  Administrate and train users on the batch Processing system through Windows 2003 Server terminals.  Perform weekly New Employee compliance orientation.  Develop training programs and modules for the Compliance Wire LMS system.  Review and Approve all clinical trial batch processing records and solution preparation records.  Maintain all GMP manufacturing records.  Facilitate Change Management programs

Supervisory level QA activities. Supervise team of 3 QA specialists and 5 on the floor specialist. Adjust team priorities based on business needs