Steve Roese Email & Phone Number

Philadelphia, Pa, Us

Miami, Fl , Us

Provided guidance for compliance, inspection readiness, and QMS oversight.

Jersey City, Nj, Us

Managed R&D QA activities (QA Oversight of clinical trials, pharmacovigilance inspections, interaction with regulatory and medical affairs, QMS oversight for new acquisitions)

Philadelphia, Pennsylvania, Us

• Providing expertise, management and consulting services, with specific expertise on organizational capability assessment, quality system improvements, and compliance remediation. • Client list included established and regulated firms engaged in manufacturing consumer products, pharmaceuticals, functional foods, and cosmetics.

Boulder, Co, Us

· Lead the Quality function for the company; managing GMP Operations, Compliance, Quality Systems, audits (internal and external), computer systems validation, and GCP/GLP oversight, including clinical trials for pipeline cancer products (3-5). All clinical trials and products (API thru commercial) manufactured by third party firms with QA oversight, audits, and management control.· Oversaw quality assurance interests and methodologies for a very successful commercial launch of one “small molecule” oncology drug (melanoma). Managed all BoH received inspections including FDA and foreign agencies. · Developed corporate quality plans, audit strategies, corporate goals, and metrics and authored the Corporate Quality Manual. Staffing included four directors (GMP Operations, Clinical QA, Quality Systems/Compliance, and Development molecules), and 14 other QA professionals. Duties included oversight of quality and compliance operations in external supply organizations (manufacturing, packaging, serialization) clinical trial operations, and call center activities.

Durham, Nc, Us

• Leading the development, operation, and management of the Marken Global Quality Assurance organization, encompassing 40+ sites worldwide, for the Clinical Trial Distribution, Pre-Clinical, and Logistics divisions• Executed a complete overhaul and improvement of the Quality Management System, established the Marken Document System, created an inspection readiness system (resulting in the dramatic improvement of client quality audit scores), established the Marken Quality Council, upgraded the CAPA Program and System, authored and established the Marken GDP internal standards, and achieved successful regulatory inspections by the authorities of Germany, Singapore, Mexico, and the USA. Strengthened the Quality Leadership and Quality Culture behavioral models.

New York, New York, Us

• Management and oversight of internal quality assurance organizations (scope and size being assignment dependent, as extensive as 11 sites and 1100 quality employees).• Product quality responsibilities have included brands such as: Advil, Centrum, Caltrate, Robitussin cough and cold formulations, Anbesol, Ativan, Solgar Nutritionals, and international brands.• Crisis management experiences have included international and domestic situations, requiring oversight of deliberation meetings, approval of press statements/releases, regulatory agency interactions, consumer contact management, and senior management communications. Acted as Primary decision-maker for product recall actions for those brands under responsibility. • Personal Professional Awards include organizational accomplishments (Silver-level award in 2005; bronze-level awards in 2007, 2006, 2004), supplier quality accomplishments (awards in 2005, 2004, 1997), and personal recognition achievements (awards in 2007, 2005 – all for crisis management situations).• Provided final approval authority for divisional Quality System policies, procedures and standards, and product-specific decisions such as product launches, FDA field alerts, recalls, and product tampering investigations. Acted as Chair of Drug Product Adjudication Team for the Wyeth European Product Compliance Initiative (OTC products).• Regulatory interaction experience includes Board-of-Health agencies such as FDA, MHRA, ANVISA, TGA, FSA, and BFAD.• Cost savings contributions (2006-2009) for sponsored initiatives exceeded $1.4 million - USD.

Paris, Issy-Les-Moulineaux, Fr

• As Plant Manager, managed all operational activities associated with the bottling of water and beverages at a state-of-the-art facility, producing 32 million cases per year. Interacted with an in-house bottle blow molding operation to insure supply, and managed all activities required to upkeep a four-mile spring water supply pipeline. Managed and assisted in the maintenance of a transportation fleet, supplying product to five regional depot locations. • As Quality Manager, responsible for the management of all quality systems and testing activities of twelve Quality departments throughout the USA and Canada. Managed activities at each spring location to insure water purity and quality and acceptable transportation practices. Performed compliance audits of each bottling site and supported quality remediation activities. Directed the National Quality Program and provided oversight activities for four third-party contract manufacturing locations, including conducting yearly audits.

Abbott Park, Illinois, Us

• As Medical Device Operations/Quality Manager, responsible for all aspects of manufacturing, quality assurance, and customer service for the Instrumentation Business Unit. Unit operations managed include media lyphilization and dispensing, robotic tray welding, circuit board bench/assembly, and final instrument assembly. Quality duties included instrument software validation and acceptance, component acceptance, media tray disposition, final instrument disposition, 510k filing support, Field Operations complaint management, and supplier management.• As Quality Director, responsible for all quality programs and systems associated with the manufacture, testing and final disposition of powdered and canned liquid infant formula. Managed Quality Assurance oversight of all quality systems, laboratories and manufacturing processes (i.e., product pasteurization and retort, spray-drying, can manufacture, and filling/packaging/finishing). Participated in all aspects of the site’s establishment (construction and start-up) as a member of the originating Site Development Team. Additional duties included managing community relations and local recruitment. Personally wrote and maintained over 85% of the original operating procedures for the site.• As Lab Manager, responsible for management and operation of all analytical laboratories employed in the in-process and finished product testing of canned liquid and powdered infant formula. Technical responsibilities included process troubleshooting, stability monitoring and product complaint analysis. Instrumentation managed included HPLC, GC, wet chemistry methods, and AA testing.