Manager Training Compliance

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.

PURPOSE AND SCOPE OF POSITION:

The Training Compliance Manager is a full-time position located at the S-12 CAR-T Manufacturing Site in the Summit West Campus, NJ. The primary focus for this role is to lead and manage the LMS Administration team. This role will also provide support to the Sr. Manager of Training Compliance by supporting the on-boarding program, gowning, train-the-trainer program, training files, and support the management of any training deviations and CAPAs for the training and learning team.

DUTIES AND RESPONSIBILITIES:

The primary responsibilities of the Training Compliance Manager are to manage the Learning Management System Administrators and the management of the system and the management of the training records. This role will also support the Sr. Compliance Manager with the new hire on-boarding program, the gowning program, and training deviations, training change controls, and training CAPAs.

Management Requirements


Support, maintain, encourage, engage and empower a learning culture for trainees, direct reports, and for the Training and Learning Organization

Manage LMS Administrator team members

Oversee projects from start to finish

Identify the appropriate number of trainers and support members required to support the business goals and day-to-day requirements for the LMS Administration team

Act as an effective change agent


Technical Responsibilities:


Align, coach, the LMS Administrators

Support the day-to-day operations for LMS Administration and Filing of Training Records

Contribute to the writing, coordination, review, approval and maintenance of the Training Program, metrics, and associated training Standard Operating Procedures (SOPs) or Work Procedures (WP)

Build rapport and understanding of CAR T operations to support and / or recommend corrective training actions and change control training requirements

Identify, evaluate and implement key performance metrics

Analyze data and lead improvement training and learning initiatives

Co-manage and deliver the global Instructor-Led (ILT) and On-the-Job (OJT) Train the Trainer Program

Co-manage and deliver the on-boarding program

Deliver gowning, and aseptic gowning programs as needed

Participate in integration activities for Learning Management Systems, as needed

Ensure training documentation/files are maintained, with good documentation practices and in compliance's with S-12 Quality Systems and retention programs

Represent the Quality Training & Learning organization at various project meetings and provide training input in the resolution of quality training-related issues

Work independently and perform with a high degree of accuracy

Partner with other members of Training teams across the organization to build harmony and alignment

Support internal and external Inspections

Apply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines and documentation practices


REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:


Strong experience and an in-depth knowledge of cGMPs, cGTPs, and cGCPs and applicable Health Authority regulations / guidelines and industry best practices for supporting a training program

Strong experience and thorough understanding of global regulatory training requirements

Strong experience and an in-depth knowledge of cGMPs, cGTPs, and cGCPs and applicable Health Authority guidelines required for managing Learning Management Systems

Knowledge of regulatory requirements for gowning and aseptic gowning program for a CAR T manufacturing site

Capable of leading and working cross-functionally to support the training requirements associated with deviations, change controls, and CAPAs

Proven experience working as a detailed oriented team player with effective planning, organization and execution skills

Innovative, proactive, and resourceful; committed to quality and continuous improvement

Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables

Effective manager

Strong deviation, change control and CAPA experience

Able to manage multiple priorities

Strong project planning skills

Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Learning Management Systems, experience with other Quality Systems (e.g. Document Management System, Quality Management System)


Education and Experience:

Bachelor’s degree with 5 years minimum of Training & Learning experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA.

OR

Highschool degree or Associates Degree with 3 years or more CAR- T experience, 5 years minimum of Training & Learning experience, and more than 15 years of experience in a pharmaceutical regulated environment

WORKING CONDITIONS (US Only):

This position is in an office and will have time spent working on a computer.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

This is the end of the Official Use document

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.

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