Bristol Myers Squibb Associate Director, GMP Training Cell Therapy in Devens, Massachusetts
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol Myers Squibb is seeking an Associate Director of Training at the Cell Therapy Facility (CTF) in Devens, MA. This role will be responsible will manage the development, implementation and sustainability of quality and technical learning solutions for the Devens Cell Therapy Facility.
This individual will lead a team responsible for developing and implementing cGMP training, and job-specific training across all functions at the site in collaboration with other Cell Therapy sites at BMS. Oversight includes, but is not limited to, driving advances in training digital technology, onboarding coordination of new hires, managing training growth, establishing traditional and blended learning solutions, monitoring training KPIs, promoting staff development through designed curricula and providing training support.
Work scope will include commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens. This role will work with Supply Chain, Manufacturing, Quality Control, Quality Assurance, Project Management, and MS&T.
This role reports to the Director of Compliance and Quality Systems for the Devens Cell Therapy Facility.
Develop and execute GxP Training strategy – including working with stakeholders to determine learning needs and priorities and provide appropriate training to meet those learning needs.
Develop training resources within functional departments to be able to identify and solve learning needs as they arise. This takes the form of Trainer certification, coaching and feedback, as well as providing system access and subject matter expertise on necessary Learning Management Systems.
Work with business Subject Matter Experts (SMEs) to agree on target training populations, craft precise learning objectives and clearly define the evaluation mechanisms and measures of success
Build and execute an effective learning mix (i.e. instructor-led, e-Learning, blended learning, social learning), in collaboration with SMEs, that is relevant for target audience ensuring all aspects of job responsibilities and expectations are met to improve efficiency, effectiveness and compliance and address gaps appropriately.
Evaluate training needs and participate in the development and delivery of training materials, for network and site initiatives, including but not limited to Quality and GxP functions as needed.
Maintain and improve onboarding experience in alignment with network deliverables.
Manage and develop direct reports by facilitating on-going performance management activities. Lead team members, foster professional development and growth, and promote teamwork and cross-functional collaboration.
Provide guidance and information to leadership on recommended training programs, curricula and training material development, and learning assignments
Manage projects and training initiatives which directly support network and GxP initiatives, to effectively implement strategic business objectives in driving quality, compliance and safety.
Support policy and procedural changes and manual design to improve the quality of the department, to include scheduled review of all existing documentation, guidelines and materials. Evaluate and report on effectiveness of the changes.
Develop and oversee departmental strategy and goals in alignment with network strategies.
Work as a training and competency expert with various teams and clients developing training material via eLearning, video, augmented reality/virtual reality and other presentations.
Verify compliance with applicable BMS Policies and Procedures and ensure consistency with other site procedures and/or specifications.
Qualifications and Education Requirements:
Knowledge of adult learning and course design generally attained through studies resulting in a Bachelor’s degree in education, instructional design, instructional technology, a related discipline or its equivalent. A Master’s degree preferred in a development/training discipline.
A minimum of 10 years of experience in learning and development within the pharmaceutical manufacturing industry or a related field is preferred, including a minimum of 5 years of leadership experience
Proven ability to create full training development cycle (assess needs, plan, develop, coordinate, monitor and evaluate)
Knowledge of instructional design theory and implementation
Strong understanding of adult learning theory, instructional design and a variety of learning methodologies.
Highly developed skills in the design development and assessment of training programs
Experience using ELMS and eLearning tools
Candidate must be familiar with and be able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMEA, Health Canada, etc.
Demonstrated leadership, communication, and motivation skills
Strong interpersonal skills and the ability to apply these within a global, matrix organization (i.e. relationship building, listening, negotiation, and conflict management).
Excellent presentation/platform skills
Excellent communication skills. Demonstrated ability to write clearly and concisely.
Ability to balance multiple assignments in a fast-paced environment
Ability to drive collaborations across functions to accomplish objectives
Strong management/leadership skills, including development of direct reports
Good computer skills including proficiency with common business software such as MS Office including database management tools.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Company: Bristol Myers Squibb
Req Number: R1534497-en-us
Updated: 2021-01-19 03:19:17.825 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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