William Coble Email & Phone Number

San Mateo, CA, US

South San Francisco, California, US

Leads and optimizes quality systems and its management to fulfill the purpose of detection, maintenance, and correction of the underlying quality process of interest (e.g., documentation, training/qualification, deviation, CAPA, change control, supplier management, product complaints). Interprets, integrates, and applies compliance signals to ensure.

Alameda, California, US

Miami, Florida, US

Leading the Quality Systems through a transformation to meet today's needs while building a robust future capability

Novato, California, US

• In my most recent role, I was responsible for ensuring the efficacy of GxP Training systems by developing quality standards and SOPs that regulate the training team and ensure consistent delivery of training solutions..
• Led the successful deployment of the training system to the Gene Therapy division and regions globally.
• Designed, developed, and deployed the Learning Program for Veeva QMS (change control, Deviation, CAPA, Product Complaints, Audits) two-year implementation, recognized as the company's best system learning program and.
• Developed operating models for Quality Systems and Training to demonstrate how work gets done.
• Expanded learning steering committee from 4 areas to 22 areas, resulting in aligned learning objectives, stronger connections from training to performance, and roadmap for learning technology adoption.

• During this time, I created and introduced learning programs and systems in a variety of cGxP fields, including Good Clinical Practices, Pharmacovigilance, and Drug Safety European Update, as well as annual GxP.
• Conceptualized and led the successful rollout of new culture initiative 'The Ways We Work" that improved morale and retention of 600 employees across the globe.
• Directly responsible for the end-to-end management, delivery, and oversight of the core training curriculum to improve employees' knowledge and skills.

Fremont, California, US

• I oversaw the policy, design, and implementation of training and development programs at Pharmacyclics. In terms of quality, enforcement, and performance, I continuously improved key indicators, accountabilities, and.
• Facilitated health authority inspection involving personnel qualification, resulting in zero observations.
• Delivered engaging, high-quality learning to employees and managed the learning system across departments.
• Developed and deployed a career process to help employees due to the closure of two-thirds of the company.

Basel, Baselstadt, CH

• My main responsibility for this position was to oversee the company-wide organizational transformation, employee development, culture building, and health authority inspection. I drove change initiatives involving.
• Remediated the 483 deficiency on the cGMP training system through the alignment of the QC Lab training with the manufacturing training processes - with Lachman concurrence/signoff and presentation and acceptance to FDA.
• Onboarded learning organization to 13 FTE's and migrated learning management system to SABA.
• Turned around production operations through the creation of 130 curricula, 175 OJT programs, 200 technical assessments, and 2 certification programs across the site.

New York, New York, US

• As a Training Manager, I was responsible for driving the company's talent growth and learning initiatives by offering real-time insights and coaching, managing workloads to ensure proper implementation at all levels.
• Eliminated 4,000 hours of non-value work through the application of LEAN tools on training processes.
• Oversaw data migration from one learning management system to another through planning, training personnel on expectations, and identifying core activities. Received formal recognition for this global record-setting.
• Administered five complete implementations of validated systems, including learning management systems (SumTotal, Plateau), assessment management sys (Pedagogue), virtual classroom (WebEx); and configuration of a.

US

Lead custom eLearning development projectsLead the global service for GSK in virtual classroom (WebEx Training Center integrated into SumTotal) to teach technical skills

Dublin 2, IE

• Consulted to Global Pharmaceutical & Biotechnology Companies to solve business issues to deliver life-enhancing medicines. Focused specifically in the Human Performance Service Line, which handles Knowledge Management.
• Portal Strategy and Planning
• Knowledge Maps
• Expert System – Decision Tree
• Communities of Practice (CoPs)Learning Management:
• Learning & TrainingChange Management:

Tallahassee, FL, US

Managed Florida State University School of Communication's interactive Lab while obtaining a Master's in Interactive Communication.During this tenure, I wrote the prosposal that lead to School of Communication being designated a New Media Center.

Ms, Communication - Interactive

Ba, Economics