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Business Transformation Pharma Bio CM GMP OD KM PMP

Location:
Mountain View, CA
Posted:
August 28, 2015

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Resume:

William Coble, PMP 813-***-**** acrf8l@r.postjobfree.com linkedin.com/in/wcoble

SENIOR LEAD: BUSINESS TRANSFORMATION

Organizational Development Learning & Development Change Management

Built scalable structures in dynamic environments with high performing people positioned in the right place.

Demonstrated experience enabling insightful engagement, innovative solutions, and continuous improvement.

Engaged with passion and purpose in hands-on and managerial roles, start small scale fast with vision.

Proven experience increasing organization effectiveness: saved organizations time 20,000 hours of time-off-work, and 4,000 hours of non-value work.

Delivered learning methodologies across classroom, on-the-job, eLearning, and virtual classroom, deploying evidence-based adult learning theory.

Certified in Change Management, Organizational Development, Knowledge Management, and Project Management.

Areas of Expertise

Learning Design and Development Change Management Program Management Systems Implementation LEAN Methodology Organizational Development Continuous Process Improvement Risk Management Vendor Management

Professional Experience

ALEXZA PHARMACEUTICALS Mountain View, CA

Director Training and Organizational Development, 1/2015 – 7/2015

Drive business transformation and learning strategy development. Ensure the right person is in the right place with the right knowledge and skills for success. Provide expertise on health authority (FDA, EMA, ANVISA) expectations and regulations related to personnel qualification.

Developed and communicated the value proposition and architecture of the organization capability building system.

Led successful health authority inspection related to personnel qualification, resulting in zero observations.

Formulated the strategy to manage the risk of the learning system across departments, qualified trainers, qualification program, and health authorities’ observations and recommendations.

Designed, developed, and deployed a career development program that generated near 100% engagement between supervisors and direct reports on career progression, career positioning, and tactical plan.

NOVARTIS, CONSUMER HEALTH Lincoln, NE

Site Leadership Team Member / Associate Director Training, 1/2012 – 1/2015

Led corporate-wide organizational transformation, culture building, employee development, and health authority inspection. Sought-after thought leader on company-wide change initiatives involving health authority responses, employee development, communications, stakeholder engagement, and adoption acceleration. Managed instructional designers, subject matter experts, and business stakeholders.

Let reorganization effort after the identifying positions that could be removed without effecting organizational effectiveness.

Enabled production’s return by re-establishing a learning department with 3% of the site’s personnel and 2% of the site’s budget. Created 130 curricula, 175 OJT programs, 200 technical assessments, and two certification programs across the site.

Achieved better systems implementation, lessons learned, better pace of change, and fuller engagement by establishing successful relationships across the company and key performance indicators.

PFIZER Sanford, NC

Training Manager, 7/2006 – 1/2012

Led change initiatives through stakeholder engagement, communication, and counseling. Challenged to close critical knowledge and skill gaps to meet regulatory requirements in a consent decree environment by leading the training function and critical

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PFIZER Continued…

learning initiatives. Managed budgets and vendors to achieve goals and deadlines. Provided expertise to health authority inspections, deviation investigations, and CAPA’s.

Removed 4,000 hours of non-value work through the application of LEAN tools on the training processes.

Successfully directed validated data migration from one learning management system to another which included moving 650,000 records in only one business day and QA sign off through planning the migration, training the personnel on expectations, and identifying the core activities. Received formal recognition for this global record-setting pace.

Supervised five complete implementations of validated systems, including learning management systems (SumTotal, Plateau), assessment management system (Pedagogue), virtual classroom (WebEx); and configuration of a document control system (Documentum).

Developed and launched a cGMP training system for the virtual manufacturing organization that covered 377 contract manufacturing sites.

PRODUCTIVITY POINT INTERNATIONAL Morrisville, NC

Engagement Manager / Global Service Manager, 7/2003 – 6/2006

Facilitated leadership and devised strategies to grow an in-sourced learning business. Oversaw the complete eLearning development lifecycle for multiple organizations. Provided learning solutions across the analysis, design, development, deployment, and evaluation phases.

Boosted number of learning sessions by 725%, scheduled sessions by 232%, and participants by 623% by utilizing a 10-step marketing and engagement program to build a virtual classroom business.

Delivered 11 eLearning solutions covering proprietary computer systems and internet ad sales training in only six months for global companies across multiple learning management systems (Docent, Aspen).

ACCENTURE Saint Petersburg, FL

Manager, Human Performance, 6/1997 – 8/2002

Conceptualized and implemented organization development and strategic learning initiatives to drive mission critical processes and employee performance improvements in the pharmaceutical practice.

Saved $1 million in travel costs and 20,000 hours of time-off-task by building a virtual classroom capability utilizing Centra for quicker knowledge uptake of field health care professionals.

Saved $50,000 in raw materials through the adoption of better decision-making tool and removal of non-value work.

Ensured accelerated pre- and post-drug launches by implementing operating models for Medical Science Liaisons, Medical Affairs, and Pharmacovigilance.

Education & Certifications

FLORIDA STATE UNIVERSITY Tallahassee, FL

Master of Arts: Interactive Communication, with distinction

GEORGETOWN UNIVERSITY Washington, DC

Bachelor of Arts: Economics

Change Management Certificate Prosci

Organizational Development Certificate Linkage Incorporated / DePaul University

Certified Knowledge Manager Knowledge Management Professional Society (KMPro)

Project Management Professional Project Management Institute

GMP Basics & Related Practices Central Carolina Community College

Elements of cGMP in Biomanufacturing Processes Wake Technical Community College



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