Compliance Training Supervisor

Profile

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.

The Compliance Supervisor is responsible for overseeing the day to day workload of a group of Training Specialists and Associate Training Specialists at the S12 manufacturing site. The Supervisor assists in determining training solutions that adhere to the Site Training Program and trains other staff members. The Supervisor is responsible for developing staff members through coaching and mentoring. The Supervisor will perform cleanroom processing duties or supervise Manufacturing operations as needed. This role will also assist the Sr. Compliance Training Manager with Change Controls, Deviations, and CAPAs that directly impact the Training & Learning Organization (TLO).

DUTIES AND RESPONSIBILITIES:


Oversees the successful implementation of training programs that meet regulatory requirements & business needs including:
Delivers gowning qualification and aseptic qualifications
Participates in Deviation, Change Control, and CAPA meetings and aids the site for training alignment for deviations, change controls, CAPA, and CAPA Effectiveness
Follows up with TLO Team to ensure that CAPA, Change Control, Action Items do not become overdue
Becomes a Change Control Owner, Lead Investigator or CAPA owner to support the day-to-day work for the TLO team
Works with the Manager to create a training and development plan to address production demands such that new hires become proficient operators and are contributing to processing stations in a timely fashion. Ensures the department training plan is being implemented and communicates any issues in a timely fashion.
Sets goals for performance and deadlines in ways that comply with business and regulatory needs.
Organizes workflow and delegation of duties and tasks to team members.
Monitors employee productivity and provides feedback, coaching, and mentoring.
Effectively communicates information between staff members and department management.
Works with the Manager on an on-going basis to implement training goals and meet KPI's.
Ensures training staff have the appropriate training and qualifications to perform their duties.
Maintains professional and technical knowledge by participating/conducting routine training events.
Hires and trains new department employees.
Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.
Collaborates with the Manager and Quality to identify trends which may require amendment to training programs.
May perform competency assessments of training staff on an ongoing basis to ensure the knowledge/skills from training are continuously applied.
Backfills for the duties of department staff as necessary.
Participates in the local Manufacturing Operations new hire Training Program including:
Promotes and exhibits core BMS values in onboarding and training activities.
May conduct ITL/OJT structured trainings for new hires to introduce to aseptic processing and GMP space, and process training.
Ensures new hire onboarding activities are completed in a timely fashion for department employees.

Maintain the Training Laboratory and equipment for cleanliness and compliance.
Perform routine inspections of the Training Laboratory to ensure proper procedures are being utilized.
Resolves issues with equipment as needed.
Complete room activity, maintenance, cleaning, and equipment usage logs (as required).
Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels.
Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.
Reports and initiates non-conformances and participates in follow up investigation when necessary.
Performs all other duties as required.


REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:


Requires a high level of understanding of cell therapy processes, controls, aseptic behaviors, cleanroom behaviors, aseptic gowning, deviation, CAPA, change control, and GMP requirements.
Advanced skills in design, development, and implementation of training.
Advanced skills in using Microsoft Word, PowerPoint and Excel.
Requires a high level of organizational and time management skills.
Ability to communicate information clearly to facilitate effective learning. This position requires speaking in classroom settings.
Requires strong interpersonal skills which enable appropriate collaboration with trainees, colleagues, and subject-matter experts.
Ability to work in an aseptic environment requiring successful completion of qualification program.
Ability to help facilitate change control discussions, determine appropriate CAPAs and write and process deviations specific to training.


Education and Experience:


B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 5-8 years of relevant experience in a clinical laboratory or blood/cell culture processing environment.


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: R1526039_EN

Updated: 2020-07-13 00:00:00.000 UTC

Location: Summit,New Jersey

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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