Associate Director Compliance Training

Profile

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.

Objective of the Position:

The purpose of this role is to ensure consistent and compliant approach for GxP Training and Qualifications within the Quality Management System. The Associate Director is accountable to drive day to day activities following standard methodology, to ensure resources are identified and aligned at the team-level to drive process improvements.

Overall Responsibilities:

Support project management, instructional design, development, delivery, and implementation of system projects.

Lead and implement change initiatives to achieve continuous improvement in the GxP training processes, including how training is developed, managed, updated, and maintained.

Interpret regulations or contact appropriate resources regarding regulations and maintain an awareness of compliance issues.

Recommend improvements to the training management process on the basis of regulatory needs, benchmarking, and opportunities for business process improvement.

Work closely with leadership and key stakeholders to ensure training is developed in accordance with current practice and functional needs based off of a risk based approach.

Create and communicate complex story of the training development and maintenance process to stakeholders.

Lead the Learning Development Managers and LMS administrators by providing guidance and direction on how to effectively, adhere to timelines, meet goals and objectives, and manage the Book of Work.

Conduct needs assessments across GxP areas.

Determine most effective learning method/modality for the purpose, and design, develop & deliver blended learning solutions.

Design and develop programs that build workforce effectiveness capabilities to optimize the end user experience and support the enterprise objectives.

Lead platform content development to create and deploy learning solutions.

Apply principles of adult learning to ensure training effectiveness and access resources to keep up-to-date on industry best practices.

Actively engage with leadership from business case development through program delivery, broker the delivery of critical programs within the portfolio, ensure organizational alignment on scope, schedule, quality, benefits and implement and monitor appropriate controls to proactively deal with barriers to completion

Navigate cross-functional team through ambiguity towards to a clear and actionable decision

Provide data and input to drive other continuous improvement efforts across the enterprise as applicable, which may include priority and timing collaboration with key stakeholders

Support regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses

Provide data and input to drive other continuous improvement efforts across the enterprise as applicable, which may include priority and timing collaboration with key stakeholders.

Lead efforts to scope, plan, and implement process improvements including accountability for sustainable improvements, such as process, procedure, systems, and training material changes; and use of appropriate change management and communication principles

Maintain awareness of Culture of Excellence across BMS

Work proactively and cross-functionally within the matrix.

Education:

Bachelor’s degree required, Master’s degree preferred

Minimum of 10 years’ experience in a regulated environment within Training and/or Learning and Development

Experience/Knowledge:

Thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality and serious breach investigations

Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities

Mastery of relevant Quality compliance processes and regulations, e.g. FDA regulations and ICH guidelines applicable to GxP

Skills/Competencies

Demonstrated influential leadership expertise and experience with senior level interactions

Demonstrated Enterprise mindset to be able to think and act across functions and divisions

Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives

Demonstrated people management experience and strategic thinking capability

Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlines

Demonstrated change agility in anticipating and leading others through change and ambiguity

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.

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, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com