A dedicated scientist and quality assurance professional, Ms. Sedor has extensive experience in global pharmaceutical development including project management, quality assurance, personnel development, outsourcing and regulatory compliance.  Her career has spanned 26 years with Johnson & Johnson in the scientific and regulatory area of small and large molecule pharmaceutical research and development.

Ms. Sedor is experienced in GxP quality assurance due diligence for licensing, acquisitions & mergers, budgets, resource forecasting, supplier quality management and IT/systems development.   

Being adept at conceptualizing, designing and implementing programs supporting internal and external quality systems, Ms. Sedor has a proven ability to perform in an international multifunctional, complex, and regulated (GLP, GTP, GMP, GCP, PvQA, ITQA, and HCC) environment.  

Through Ms. Sedor’s accomplishments one can easily recognize her effective leadership competencies, forward strategic thinking and ability to facilitate continuous improvement while optimizing resources.  

EXPERIENCE

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.            1982 – 2009

Most recent position:  Director, External Quality Assessments, Global R&D Quality Assurance

·         Established and maintained an effective program for GxP quality assurance due diligence/audit, project management and integration of Licensing & Acquisition, Merger & Acquisition and Out-licensing opportunities contributing to the successful in-licensing and improved timelines for integration of products in the Johnson & Johnson Pharmaceuticals sector. 

·         Developed strategy and implemented a cross-functional, cross-GxP consortium of Quality Professionals from across the Johnson & Johnson Operating Companies to optimize leveraging of supplier quality resources and lean processes.

·         Provided leadership through consultation, risk assessment, crisis management and business continuity planning resulting in a high level of regulatory compliance support and business stability within the Johnson & Johnson Pharmaceuticals sector. 

·         Facilitated transformation of the quality culture as a member of the Quality Assurance Leadership Team focusing on improving the business through positive quality solutions.

·         Developed personnel through influence and mentoring leading to an effective team within quality assurance.  Exported talent to other organizations within Johnson & Johnson.  Developed and facilitated training programs.

·         Managed the Preclinical Quality Assurance (GLP QA) Group in addition to developing and implementing the R&D Quality Assurance Due Diligence program supporting both small and large molecule drug development. 

·         Provided cross-company regulatory guidance through collaboration and teamwork with functional groups to ensure a high level of compliance oversight and audit activities including preclinical study specific, facility and health authority inspection readiness audits under FDA and ICH guidelines.

·         Effectively applied risk management and resource optimization to support the business resulting in timely and efficient review and processing of documents and audits while managing multiple projects and deadlines simultaneously.

·         Proactively planned and directed audits and training for inspection readiness for QA and the business partners within J&JPRD and Centocor R&D contributing to successful regulatory inspections over the next several years.

·         Study Director/Study Monitor responsible for multiple internal and outsourced GLP and Exploratory in vivo and in vitro Genetic Toxicology and Reproductive/Teratology studies in support of FDA and Foreign Regulatory Submissions.

·         Supervised general laboratory operations including training/recruiting of associate staff and interns.

·         Led regulatory readiness program and participated in numerous internal and external - Health Authority and Quality Assurance Inspections in support of preclinical development.

·         Computer system development (including inception, design and validation), maintenance (change control, termination of life cycle) and release of laboratory computer systems.

EDUCATION/CERTIFICATION

                                                            BS, Toxicology (cum laude)                                                               

University of the Sciences in Philadelphia
(Philadelphia College of Pharmacy and Science), Philadelphia, PA

PROFESSIONAL ORGANIZATIONS/AWARDS

Association of Clinical Research Professionals

Society of Quality Assurance -Biotechnology Subspecialty Section

British Association of Research Quality Assurance -Due Diligence Working Party

Johnson & Johnson Pharma R&D Encore and Vision Awards for Leadership and Performance             

Chairman of the Board of Trustees Award - May, 1983 (Philadelphia College of Pharmacy and Science)