• Lead R&D Clinical Supplier Audits and maintain Annual Audit Schedule • Maintain Supplier Qualification approval (Quality Agreements, Risk Reviews, and Audit Cycle) • Maintain Approved Supplier List for Clinical R&D suppliers • Maintain Global Lead and Supporting auditor qualifications for Clinical R&D team • Implement Veeva eQMS, eDMS, eLMS • Lead QA compliance activities for R&D Clinical Studies Team • Develop or Improve Quality Systems SOPs and standards • Develop and maintain Clinical R&D quality metrics (dashboards, and reporting at quarterly Quality Management Reviews • Maintain matrix of External Supplier notifications

• Lead Expansion of manufacturing facility for API production quality • Lead software validation for manufacturing operations • Lead a team of Quality Engineers and Technicians in further development of cGMP quality system • Lead cross plant meetings between US based sites • Representative for Regulatory authorities

• Lead the development and Improvement of Global Quality Management Systems• Develop Global Standards, serving as SME or trainer for both Regulated and Industrial businesses• Lead Global training to harmonized basic Quality Systems expectations across all plants• Lead Global training to improve local plants providing them tools to meet certification revisions with a focus on risk management and mitigations • Lead Global Certifications for 54 plants with a diverse customer base from API, Food, Cosmetics, and Industrial, Medical Device.• Lean quarterly Management Review of Global Systems• Develop Systems that allow business teams quality information for sales initiations.• Serve as Lead Auditor for Plant-based recertification audit preparations

• Lead and direct the Quality Assurance and Quality Control teams• Lead the development of collaborative alignment between plant Quality and Operations Units.• Lead functional realignment of the Quality Organization• Lead Quality Agreement discussions with major customers globally (Pharmaceuticals and Food)• Hosted 32+ customer and third party audits annually.• Lead complex processing quality issue resolution.• Lead interplant collaborations and annual global inter plant Quality Improvement Team• Divisional Business Lead for developing corporate Quality Systemo Lead development of Management of Change module o Lead Quality Audits module development• Lead GxP auditor for international supplier development audits• Lead preliminary advice on regulatory concerns for the plant.• Lead direct customer discussions on product improvements or special requirements.• Developed improved plant quality feedback loops to improve response time to identified opportunities.• Lead cross-functional teams to resolve complex quality processing opportunities.• Lead the implementation of more robust quality analysis tools.• Achieved FSSC:22000 certification in a time collapsed schedule on arrival• Achieved Recertification of ISO 9001:2008 on arrival.

BioMedical Division Membership Chair, Linked-In Owner, Coordinator, Education ChairSectional Linked In support, Education Chair

Provide guidance on the establishment of either, pharmaceuticals, biologics, or combination products to enter the highly regulated markets of the US from other nations. Provide on going support for current or New products to gain marketing approvals through development and implementation of apprpriate quality systems.

• Develop and Integrate quality management system for the Gore PharmBIO products.• Lead a team of Engineers, inspectors, to collaborate to solve quality related issues.• Develop and implement Supplier Quality programs including audits and interactions with process and product engineers• Develop and implement electronic Quality Management system and align with divisional systems• Develop and implement appropriate cGMP practices and retain and improve on current ISO 9001:2000 standards.• Provide Regulatory consulting to NPD Biotechnology and Pharmaceutical opportunities.

• Design and develop facility and Array (Class II Medical) Recruited and directed training of department Staff. (5-14 quality engineers and technicians)• Led interdepartmental problem-solving teams, process metric development, new product introduction and supplier quality.• Resolved quality issues for external and internal customers’ needs. (managed > $250K critical process material)• Directed local cGMP division development efforts for bringing parts of micro array development to medical device manufacture standards. • Key leader and contributor in achieving ISO 19001-2000 divisional compliance and development of GMP and ISO 13485 standards and practices.• Resolved external customer issues to recover possible lost business and establish acceptable quality practices, saving >$250K of potential losses • Directed efforts to present academic teaching gifts nationally >$360K, providing good citizen brand recognition and equitable tax benefits. (Rhodes College undergraduate and Vanderbilt University graduate studies)• Improved corporate quality within Delaware, serving as an Examiner for the Delaware Quality Award.• platform.

• Negotiated with academic customers and external vendors. • Completed array equipment purchases, • Managed Facility and staff development. Budget >$500K• Directed quality control functions with external suppliers, managing > $250K critical process materials• Consortium (Cancer Genome Characterization Center at Harvard Medical School) members utilize Agilent platform for Micro Array studies (2006).

• Originated quality control team and laboratory (7 scientists and technicians). • Directed cross-departmental collaborations to bring new products to market and improve quality standards on existing products. • Led the development of measurement standards and metrics for existing and new products.