Kenneth Ray Email & Phone Number

Co-developer and Practice Lead for Quality Pulse® quality culture diagnostic, working with Life Sciences companies to assess their Quality Culture and develop outcome-based improvement plans.The Quality Pulse® quality culture diagnostic is a scientific, research-based quality culture assessment model designed specifically for FDA-regulated and life.

Long Valley, NJ

I work with organizations as they embark on strategic change or face challenges/duress. I use a Compliance ReimaginedTM methodology to leverage synergies between Five Domains--- Strategy, Governance, Compliance, Transformation, and Learning, to achieve desired outcomes.TECHNICAL EXPERTISE: System Analysis & Design Thinking, Learning Strategy, Quality.

Summit, NJ

• In a project sponsored by CEO/CIO/CHRO and CCO, led an enterprise-wide transformation of learning.
• Comprehensive assessment of current state learning technology and processes.
• Developed future state vision, strategy, governance and operating model
• Addition of “Curiosity and Continuous Learning” to Corporate Values
• Implemented Workday Learning as a common technical platform, with transition plan.
• Implemented a Managed Service Delivery model for new learning content

Summit, NJ

• Reporting to the Chief Compliance Officer, responsible to identify and develop enterprise quality and compliance initiatives, strategies, and provides leadership and governance to comprehensive governance and.
• Developed an enterprise GRC risk model using Bowtie methodology to consolidate compliance risks across multiple regulatory/compliance domains at request of the Chief Compliance Officer.
• Aligned and led governance of 12 cross-functional GxP QMS & compliance processes, integrating metrics and reporting into a single enterprise compliance/risk/governance technology system.
• Cross-functional technology governance processes externally recognized as “best practice” in field.

Responsible for developing and implementing a global quality system for all Celgene sites worldwide, coordinating and monitoring key quality metrics on a global basis, and a member of the Global Quality and Compliance Leadership Team. Developed and implemented a global, scalable, integrated quality management system, including a single technology platform.

Responsible for leading and managing PSQ staff located in both the US and Werthenstein AG (WAG), Switzerland, with the goal of optimizing Quality Strategies to ensure that effective and efficient global processes are in place which are compliant with local Swiss law, EU GMPs and the Clinical Trials directive, and FDA GMP requirements. Led strategic.

Responsible for the development, implementation, training, and assessment of global pharmaceutical manufacturing quality policy and standards to meet US FDA and International Good Manufacturing Practice (GMP) regulatory requirements.

Responsible for the development and execution of global quality system improvement projects. Major accomplishments/projects:Global implementation, training, and compliance assessment of GMP standards across 19 strategic sites in the US, Puerto Rico and Europe. Developed, validated and implemented a glboal, web based assessment tool, with real time.

Kalamazoo, Michigan Area

Site quality leader and member of site leadership team. Responsible for all Quality Assurance functions, and QC/GMP labs for API release testing and a 24x7 in-process laboratory, supporting of one of world’s largest API sites. API products included corticosteroids, antibiotics, cephalosporins, controlled substances, sterile APIs, micronized products.

Ms, Analytical Chemistry

Activities and Societies: President, Graduate Student Body Secretary, American Chemical Society Ole Miss Local SectionCharles Hussey.

Bachelor Of Science - Bs, Forensic Chemistry

Activities and Societies: Director, University Relations Chairman, Ole Miss Ambassadors Chairman, Traffic Appeals Board Race Relations.