Associate Director, Compliance & Training Resume
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Resume:
ALITY-DRIVEN COMPLIANCE AND 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.
Core Competencies
* Compliance to Government Regulations & Industry Standards
* Quality Management Systems
* Change Management
* GMP, SOP & Systems Training
* Investigations/CAPA
* Curricula Development
* Document Management
* Enterprise Systems/SAP
* Supply Management / Strategic Sourcing Best Practices
* Packaging Materials / Structures
PROFESSIONAL EXPERIENCE
Wyeth Pharmaceuticals (now Pfizer), Collegeville, PA
Associate Director, Compliance & Training (-)
Promoted from Manager to Senior Manager to Associate Director. 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.
* Led development and maintenance of Wyeth manufacturing, packaging, and labeling policies, conformance standards and division directives affecting in excess of 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 $ million global enterprise-wide change control system that resulted in the elimination of separate change control systems.
* Implemented risk-based management approach to periodic review cycles and training methodologies for procedures that reduced biennial reviews of + procedures by % and non-essential classroom training for + employees by %.
Manager/Team Lead, Pharmaceuticals Team ()
Managed a team of package engineers, labeling project administrators, and graphic artists in the design, development and maintenance of packaging materials, bills of material, specifications and labeling.
* Ensured on time delivery of packaging and labeling components for global new product launches for branded and generic businesses totaling in excess of $ billion in annual sales.
* Led design of new processes and procedures related to deployment of Technical Specifications System.
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 contract package engineers in support of packaging documentation conversion effort.
Packaging Engineer ()
Supported deployment of $ million Technical Specifications System as business client liaison ensuring system design was aligned to corporate and manufacturing site needs.
* 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.
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.
Thomson Consumer Electronics (formerly RCA), Deptford, NJ
Inventory Management Planner
Planned, purchased and managed inventory of $ 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.
* Reduced annual picture tube inventories by % and warehousing costs by %.
Scott Paper Company (now Kimberly-Clark), Philadelphia, PA
Sr. Supply Management Specialist/Purchasing Agent
Promoted from Senior Purchasing Associate to Buyer to Senior Buyer to Senior Supply Management Specialist. Negotiated contracts totaling in excess of $ 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.
* 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 $ million.
EDUCATION
Widener University, Chester, PA
Masters of Business Administration/Concentration in Marketing & Finance
* % completed with GPA .
Bachelors of Science Business Management /Certificate in Marketing, Summa cum Laude
* Member Phi Kappa Phi National Honor Society
* University College School of Management Award
PROFESSIONAL COURSES AND CERTIFICATIONS
Effective Negotiating Skills, Strategic Cost Management, Statistical Process Controls, Procurement Capability, Leadership and Trainer Qualifications, Lean/Six Sigma, and Change Management Techniques
Six Sigma Red Belt Certification –
ADDITIONAL SKILLS/QUALIFICATIONS
Mainframe and PC-based systems including:
* Purchasing, materials and distribution requirements planning systems such as SAP, ASI, and HP.
* Documentum and NovaManage document management systems.
* MS Office products including Excel, Access, Word, Visio and PowerPoint.
* Learning Management Systems – ISOTrain & SumTotal
