Senior Compliance & Training Manager with progressive and in-depth experience in regulatory requirements and industry standards for Pharmaceuticals, Biologicals/Vaccines, Nutritionals, and Consumer Healthcare products. Adept at integrating quality and regulatory standards into business processes, enterprise systems and training programs; directing cross-functional business teams; and negotiating supplier sourcing and quality agreements. Skilled in synthesizing SAP and Documentum into business processes and implementing change management and training strategies across multiple functional areas in dynamic environments.
Jan 2000 - Nov 2009
Associate Director, Compliance & Training
Directed the development and maintenance of a Global Packaging and Labeling Quality Management System, ensuring the creation of effective and efficient business processes, training programs, corrective and preventative action plans, and enterprise system designs that were compliant with Corporate policies, government regulations and/or guidelines, and industry standards. Selected Accomplishments: • Led development and maintenance of Wyeth manufacturing, packaging, and labeling policies, conformance standards and division directives affecting in excess of 50 facilities resulting in uniform global standards for regulatory compliance. • Directed change management and training programs associated with new or revised regulatory requirements, system implementations, and emerging business practices resulting in timely and compliant deployments. • Led Human Performance and Training Effectiveness audits of processes and systems resulting in the elimination of compliance gaps and improvements in the quality and efficiency of outputs. • Led cross-functional business and information technology teams in the development and implementation of an $85 million global enterprise-wide change control system that resulted in the elimination of 15 separate change control systems. • Implemented risk-based management approach to periodic review cycles and training methodologies for procedures that reduced biennial reviews of 100+ procedures by 50% and non-value added classroom training for 120+ employees by 70%.
Mar 1999 - Jan 2000
Manager/Team Lead, Pharmaceuticals Team
Managed team of 14 package engineers, labeling project administrators, and graphic artists in the design, development and maintenance of packaging materials, bills of material, specifications and labeling. Selected Accomplishments: • Ensured on time delivery of packaging and labeling components for global new product launches for branded and generic businesses totaling in excess of $10 billion in annual sales. • Led design of new processes and procedures related to deployment of Technical Specifications System.
Jan 1999 - Mar 1999
Manager/Team Lead, Technical Specifications Conversion Team
Established satellite facility to support North American deployment of Technical Specifications System. Recruited, hired, trained, and managed a team of 20 contract package engineers in support of packaging documentation conversion effort.
Jan 1998 - Jan 1999
Supported deployment of $12 million Technical Specifications System as business client liaison ensuring system design was aligned to corporate and manufacturing site needs. Selected Accomplishments: • Established usage standards, assignments to teams, and provided user training. • Performed database administrator functions including workflow design and development, system maintenance, user provisioning, and support for IQ/OQ/PQ testing.
Sep 1995 - Jan 1998
Product Specifications Engineer
Provided packaging project management support to Wyeth facilities related to new product launches and/or new packaging design implementations, ensuring on time delivery of specifications, labeling components, and bills of material. Coordinated efforts between package engineering, labeling, and manufacturing / packaging facilities.
Feb 1995 - Sep 1995
Inventory Management Planner
Thomson Consumer Electronics (formerly RCA)
Planned, purchased and managed inventory of $12 million+ in electronic replacement parts and MRO items for RCA, GE, and ProScan television sets, both domestic and international. Developed monthly forecasts and yearly business plans. Selected Accomplishments: • Reduced annual picture tube inventories by 20% and warehousing costs by 15%.
Jul 1985 - Oct 1994
Sr. Supply Management Specialist/Purchasing Agent
Scott Paper Co. (Now Kimberly-Clark)
Promoted from Senior Purchasing Associate to Buyer to Senior Buyer to Senior Supply Management Specialist. Negotiated contracts totaling in excess of $12 million annually for packaging materials supporting consumer, commercial, healthcare and emerging new markets businesses. Provided purchasing/packaging design/development support to contract manufacturers/packagers in the development, sourcing and effective use of packaging materials. Selected Accomplishments: • Led Packaging Supply efforts to identify continuous improvement opportunities and transaction reductions through the use of Evaluated Receipts Settlement programs, source reduction programs, and supply contract improvements resulting in annualized savings in excess of $1 million.