James W. Carroll Jr.

* ******* **. * ****: 551-***-****

Robbinsville, NJ 08691 acxbpm@r.postjobfree.com

Summary of Qualifications

Quality and Compliance leader, with over 25 years of regulated pharmaceutical experience. Deliver strategies that build compliant quality systems and enhance all levels of GxP employee performance, improve process efficiencies, and aligning with business strategy. My diverse background incorporates manufacturing, QA, GMP, R&D, compliance, auditing, learning & development, and regulatory affairs, with successes involving:

Quality System Governance

Training System Development

Technical Training

Educational Partnerships

Quality System Ownership

Knowledge Management

Change Leadership

Needs Analysis/ Process Improvement

Training Effectiveness

System Implementation (LMS)

Quality System Effectiveness

GxP Training Solutions

Professional Experience

Sun Pharmaceuticals

Head Corporate Quality Policies, Training, & Communications March 2016 to present

As a member of the SUN Pharma Quality Leadership team, responsible for the development and implementation of global policies and standards ensuring alignment to regulatory requirements. Responsible for development and implementation of the overall Sun Corporate Quality Strategy for Global Policies, Standards, Training and Communication.

Biogen

Director Global Quality, Training & Development 2013 to Dec 2015

Directed the development and implementation of all GxP training programs within the Pharmaceutical Operations & Technology organization globally. Defined and drive the implementation of GxP global training strategies to meet customer needs, ensure regulatory compliance, and develop best practices. Partnered with key stakeholders, groups and executives to create robust and efficient training solutions. Created, maintained, and continuously improved of all GxP learning systems, processes and procedures globally. Business owner of the Biogen validated learning management system (LMS). Ensured accurate communication and delivery of policy and procedure training globally.

GlaxoSmithKline

Director Global Regulatory Affairs, Professional Development 2011 to 2013

Defined and directed the global professional development strategy and needs across Global Regulatory Affairs (GRA) ensuring timely delivery of training and education programs to staff and key customers. Through excellent networks within and external to GRA, anticipated and established learning needs and required professional development programs to establish and maintain GRA as the premier regulatory affairs function.

Bristol-Myers Squibb Co.

Associate Director, Global Learning & Knowledge Management 2007 to 2011

Responsible for the development and implementation of Learning Content Information Architecture strategy (Knowledge Management), focused on aligned taxonomy, metadata and nomenclature across learning systems (SharePoint, LCMS, LMS). Delivered improved learning content management, search and re-use.

Provide leadership to R&D personnel regarding Knowledge Management, conducting formal Lessons Learned sessions focused on improving process, capturing best practices, and improving organizational effectiveness. I developed and maintained R&D Guidance Documents, and facilitated communities of practice. Developed and Lead R&D Learning Governance Council focused on alignment of training resources, learning effectiveness and best practices.

Élan Pharmaceuticals

QA Consultant, Training 2007

Developed strategy for Élan GMP training system establishing a training plan that includes sustainable compliance tailored to business needs, provided guidance, leadership, and expertise regarding compliance, quality, and GMP issues while providing solutions to training system issues, serving as leader of site training and learning management system implementation.

Schering Plough, Kenilworth, NJ

Associate Director, Compliance Training 2005 - 2006

Head of Pharmaceutical Sciences Compliance Training Organization, responsible for training system ownership and oversight of learning for 1200 GMP/GSP employees. Harmonized training activities across 7 business units, aligning compliance related training activities, while providing Quality Training System leadership and strategic direction.

Key contributions include:

Integrated training and systems resources to increase the use of technology (e-learning) for training delivery.

Established and led the Training Management Council, creating training governance across Pharmaceutical Sciences for training/compliance issue resolution, sharing of best practices, and continuous improvement.

Instituted a formal metrics system to maintain a 90% training compliance across each source area within PharmSci improving compliance to training curricula by 20%.

Regulatory Inspection point of contact for all training system and compliance requests.

Functioned in a key leadership role with multiple international business partners, across Schering-Plough designed to aid in the closure of Consent Decree requirements.

Developed internal system audits to address and mitigate consent decree issues, eliminating training related findings.

Purdue Pharmaceuticals, Totowa, NJ

Sr. Manager QA, GMP Training 2004 - 2005

Provided management and administration of all activities conducted by the QA GMP training group, including the development of formal strategy, process, administration, delivery assessment, and improvement. I provided leadership, guidance, instructional design, needs analysis, and compliance expertise support to training staff, focusing on accountability, growth, and a proactive approach to training. Managed the compliance and standardization of GMP programs, procedures, and the administration of SAP training system across multiple sites, and developed an internal QA training audit program.

Wyeth Vaccines, Sanford, NC

Manager, Training and Continuous Improvement 2001 - 2004

Developed and managed site wide training system, establishing site wide training compliance and curricula development.

Create a compliant state of the art training system for $100 million manufacturing facility including SOPs, training materials, and system implementation plans. I was the recipient of Wyeth Global Recognition “Best Practices Award” for Training System. Was recognized as SME consultant on Consent Decree issues, as member of several compliance teams, and utilized learning needs analysis to create task-based curricula for all manufacturing personnel.

AAI International, Wilmington NC

GMP Manufacturing Training Manager 1998 - 2001

Led several key initiatives outside the scope of training function, provided project management leadership, technical expertise across business unit. Established partnerships with HR, and department management and developed and implemented Career Path initiative for entire manufacturing area creating formal skills based progression system, improving employee retention by 35% in the first year. I received the AAI President’s Award, for establishing training needs for clinical and commercial manufacturing areas, including the planning, developing and delivery to all manufacturing personnel. Responsible for managing a $5 million "high toxicity granulation suite" project from installation, through validation and startup, generating $25MM in revenue during the first quarter of use.

Novartis Pharmaceuticals, Suffern, NY

Technical Trainer/Team Lead 1985 - 1998

Functioned as a manufacturing team lead, responsible for all phases of manufacturing solid dose products, including “on the job” training for employees. Responsible for the development of over 600 formal training modules in support of site training activities, and successfully executed classroom and hands on technical training events to support GxP operations.

Education

BS - Business Management & Organizational Development Mount Olive College, Mt. Olive NC.

Qualifications and Certifications

Trackwise, ISOtrain, SABA, SAP-QM, Plateau, Sum Total LMS systems qualified

ISPE Train the Trainer Certified

Pharmaceutical Training Institute Seminar - Conducting Internal Audits and PAI Inspections.

Completed ISPE Seminar on Auditing for GMP (GMP Institute)

Completed ASTD Certification: Managing Organizational Knowledge

Completed BMS Lean Sigma Training

Professional Affiliations

Member American Society for Training and Development. (ASTD) since 1996

Member GMPTEA (Training & Education Association) since 1995

Member AGXPE (Association for GxP Excellence) since 2013

Member of ISPE since 2000

Member of PDA since 2005

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