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.

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.

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.
• 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.
• 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.
• Regulatory interaction experience includes Board-of-Health agencies such as FDA, MHRA, ANVISA, TGA, FSA, and BFAD.

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.
• 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.

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.
• 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.
• 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.