Roger Voight Email & Phone Number

Greater Chicago Area

I have retired as of June, 2019

NORSK CONSULTING, INC., Libertyville, IL A consulting firm to the FDA regulated industries, with a focus on cGMP compliance management, project management and regulatory services. Principal/Independent Consultant•Provide comprehensive “hands-on” project and process management and compliance consulting services in Quality Assurance, Quality Systems, Pharmaceutical Operations and Validation processes. Development of work product deliverables based on a process of strategy development, assessment and audit, operations management and process improvement. These services are provided to a broad spectrum of clients (e.g. Abbott, ACS Dobfar, Alpharma, Catalent, CH2M HILL, Genzyme, Hospira, J&J, KV Pharm, Mallinckrodt, Mylan, NIH, Novartis, Philips Healthcare, Sanofi-Pasteur, Wyeth) in pharmaceutical, biotechnology, vaccines and medical devices.•Long-term interim QA/QC management for multiple clients: parenteral dosage forms, biotech pharma, vaccines, solid dose, API and medical devices.•Quality Systems (including CAPA) development and implementation.•Remediation development, management and implementation: Consent Decree•Site commissioning, start-up and operational sustainability support.•PAI readiness preparation, development, implementation and management.•Process evaluation and assessment, gap analysis, remediation and improvement management, including Risk Management (aseptic fill, biotechnology, solid dose and medical device). FDA MDR/MDV/ADE.•20 years of sterilization systems development, implementation and management for radiation, ETO and steam processes.•Development and implementation of internal and external audit programs.•cGMP compliance and process training programs (CFR 21: 11, 58[GLP] 210, 211, 314, 600, 820, 1300; ISO: 9001,13485,14971,11135&37,14611; GTHF; ICH: (Q7-Q10).•Extensive experience with ANDA, NDA, BLA, PMA and 510(k) submissions

Manufacturer of Active Pharmaceutical Ingredients (APIs), Excipients and Fine Chemicals, supplying the pharmaceutical industry with constituents for parenteral, biotechnology, vaccines and solid dosage forms; including treatment of cancer, diabetes, arthritis, Crohn’s disease and sickle cell anemia. Position a 1-year contract• Provide comprehensive quality and compliance management for commercial production of pharmaceutical APIs and related compounds. This role requires the knowledge of hands-on plant expertise as well as the oversight skills to manage offshore supply chain processes of critical API components. • Instituted and maintained a “culture of sustainable compliance”.• Principal contact for all regulatory agency activities.• Developed and implemented compliance site strategic and tactical planning processes that encompassed and integrated all phases of the manufacturing and quality processes.• Developed and responsible for cGMP compliance strategy and tactics, gap analysis, remediation and execution for all compliance programs and processes. • Responsible for division Quality Systems, including CAPA.• Maintained client DMFs.• Initiated and implemented a codified Training Program.• Initiated, developed and implemented systems for internal/external audits.• Remediated and implemented enhanced Environmental Monitoring program.

Deerfield, Il

.UNIMED PHARMACEUTICALS, INC.A Solvay Pharmaceuticals, Inc. Company, Deerfield, ILA $300 million manufacturer and marketer of ethical solid dose, capsules and gel sachet pharmaceuticals. Postion a 1-year full employment contract. •Managed Quality and Compliance for the commercial manufacture of ethical solid dosage pharmaceuticals. Unimed, a virtual company, all API and finished drug product manufacturing operations outsourced to global third-party contractors. •Developed and executed strategic initiatives for both QA and Operations.•Developed and implemented cGMP compliance strategy, gap analysis, including process execution for compliance oversight responsibilities. •Executed global supply chain validation of all vendors, raw materials, API, manufacturing operations, packaging and labeling, secure product transfers and finished product warehousing and distribution.•Ensured that the operations of Unimed and its’ contractors met all applicable regulatory requirements.•Developed and implemented Quality Systems, including CAPA and complaints•Performed extensive cGMP training program for all employees and contractors.•Re-established and implemented comprehensive corporate audit system.

Managed plant quality assurance/quality control and regulatory functions for the manufacturing of generic and ethical parenteral and lyophilized pharmaceuticals. Developed partnership with site Operations to harmonize facility goals and functions. Served as primary liaison with all applicable regulatory agencies. Successfully managed annual budget of $4.5 million, with staff of up to 100.•Site lead in AIP remediation, addressing and reducing existing 80 item 483 to 0 items, via subsequent FDA inspection, in a time-frame of 9 months.•Implemented supply chain process control via on-site audits and partnerships with component, labeling, API and excipient vendors.•Reduced total product release time by 50+%.•Implemented computerized SPC in filling/capping areas.•Implemented self-inspection process in manufacturing areas.•Successfully managed FDA, cGMP and PAI inspections, reducing observations by 85% for over five years.•Evaluated processes and reduced costs by 40%, with improved productivity.1990 – 1991 Quality Assurance Sterilization Project AdministratorDesigned and directed sterilization and validation activities at three manufacturing sites and contract vendors for gamma radiation, ETO and processes. Prepared and executed protocol studies, corporate sterilization policy and manufacturing technical support.•Served as interim QA Director at Puerto Rico, New York and Illinois manufacturing facilities.•Built and staffed Terminal Sterilization Laboratory.

Attained extensive breadth and depth of knowledge in the areas of quality, compliance and quality operations in the pharmaceutical, medical device and diagnostics industries. Employment histories during this period were positions of steadily increasing responsibility and authority including such firms as:• The Upjohn Company: solid dose• Baxter International: diagnostics • G.D. Searle & Co. (Will Ross Div.): medical devices/ADE/MDR• Organon Teknika (Akzo Nobel): TICE BCG Vaccine• Respiratory Care: aseptic fill/medical devices/ADE/MDR• Sterigenics: contract gamma sterilization• Joseph Schlitz Brewing Co: beerYears of Experience/Expertise in Quality,Compliance and Regulatory Affairs:• Pharmaceuticals:  Parenterals: 20+ Solid Dose: 10 Liquid Fill: 10 API: 9+• Biopharmaceuticals/Biotechnology: 12• Medical Devices: 10• Diagnostics: 5• Vaccines: 4 Primary contact for all regulatory agencies for over 25 years (FDA (cGMP/PAI/Warning Letter/Consent Decree), DEA, OSHA, EMA. Responsible for management of site/company inspections, observational responses and systematic follow-up. Maintained excellent relationships with all government agencies.

Ms, Microbiology

Activities and Societies: Graduate Teaching Assistant

Bs, Biology/Chemistry

Activities and Societies: Beta Beta Beta Biological Society, Phi Mu Alpha Fraternity (music), Undergraduate Teaching Assistant.