Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
PURPOSE AND SCOPE OF POSITION:
The Manager, Global GMP Training and Documentation role supports the training needs of GMP Departments.
This position is responsible for the development of site and global curriculum, technical training
programs, and Global Quality Systems training programs and implementations.
This Manager consults with management in the development of training programs and
The Manager designs and facilitates technical training using a variety of modalities
Bachelors Degree preferred OR an equivalent combination of education and experience.
8+yrs of GMP, Quality experience.
5+ yrs of GMP Training experience
Knowledge, Skills, and Abilities
Must have expert GMP, Quality, and in-depth risk management knowledge.
Must be able to effectively prepare communications with interpretation of data analysis and
potential problems to management and the group with clarity and a high level of accuracy.
Must provide guidance to other employees in the interpretation of technical issues across a
majority of the job function and manage development of technical initiatives and activities by
interdisciplinary teams. Must develop employees and coach them to bridge knowledge gap.
Most have strong authorship and be able to critically review reports while effectively inputting
and expressing Quality risk management principles.
Must be action-oriented and customer-focused and skilled in decision-making, building
relationships, problem solving, conflict management, planning and organizing, resource
allocation, coaching others, and analytical thinking. Must possess an independent mindset and
Demonstrates expertise in managing the Learning Management System and is a global leader
for technical troubleshooting and support.
DUTIES AND RESPONSIBILITIES
Responsible for the development, creation, delivery and facilitation of Technical Training
Consults with department management to develop department training programs and
Administers the local GMP Training program, and works closely with the Associate Specialist,
Global Quality Systems to facilitate the interaction of Document Management with the Learning
Management System and approve documents and process training requests.
Supports Global Quality Operations Systems training programs and implementations.
Participates in the Quality System implementation process for upgrades and new systems.
Works with Department Managers on an on-going basis to prioritize training needs and to verify
the effectiveness of cGMP training.
Demonstrates expertise in all Global Quality Operations Systems, including but not limited to
Change Control, Deviations/CAPA, Product Quality Complaints and Document Management.
Demonstrates proficiency in training content creation, and interviews key stakeholders to
develop specific training content to meet business needs.
Develops, facilitates and conducts Annual GMP and Qualified Trainer training.
Works independently with minimal supervision.
Forward thinking, seeking opportunities to positively impact the organization.
Performs other duties as assigned.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.