Senior Quality Training Specialist

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

Located at our Indianapolis, IN facility, The Quality Training Specialist will be responsible for supporting the training management processes related to manufacturing and distribution of clinical trial and commercial products for RayzeBio programs. Responsibilities also include supporting implementation of and adherence to the quality procedures. Additionally, the Quality Training Specialist will become a subject matter expert (SME) in management related to quality systems. The Quality Systems team is responsible for enabling development and operations of the RayzeBio Indianapolis site by ensuring compliance to regulations and the Quality Management System (QMS).

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Assist with the implementation of the RayzeBio Training Management program
• Setup new users in electronic Quality Management System (eQMS)
• Maintain training matrices for all site roles in coordination with department leaders
• Assign new eQMS users with training courses as required per the training matrices
• Organizing instructor led training courses with site SME instructors
• Update eQMS users with training courses as required when changing roles
• Inactivate uses in eQMS when they leave the company
• Ensure that Trainers/Instructors have documented expert training evidence or ‘train-the-trainer’ justification in their training records
• Participate in establishing training best practices and processes to build a comprehensive on-the-job training program
• Working with Human Resources to ensure all site personnel maintain updated job descriptions and resumes at least annually
• Coordinate recertification of personnel for required testing such as vision screening
• Manage, organize and maintain all site personnel training records electronically and/or physically
• Assist with the establishment of policies and standard operating procedures to ensure compliance with GXP regulations as required
• Assist with continuous improvement projects to improve the Training Management program
• Provide tactile support with the day-to-day processes focused on KPIs to ensure compliance and on-time completion of all required training
• Build strong partnership and collaboration with internal stakeholders such as R&D, Production, Engineering, QC, QA, EHS and Human Resources to drive and align on agendas and priorities
• Support audits as a SME of the Training Management Program and/or provide requested training records for auditors

Long-term:

• Support the efforts to commercialize the distribution of current clinical programs upon FDA approval

Education and Experience

·BS degree in related field (Education, HR, Science, Learning & Development preferred)

·2+ years of proven experience in a training role (cGMP experience preferred)

·Demonstrated working knowledge of quality management systems and learning management software (LMS)

·Demonstrated working knowledge of working in a cGMP facility (preferred)

·Demonstrated experience in managing a training program for 50+ employees

Skills and Qualifications

·Possess the ability to manage multiple priorities in related disciplines to meet goals

·Demonstrated knowledge in cGMP processes and training record requirements

·Excellent professional ethics, integrity, and ability to maintain confidential information

·Highly motivated and organized professional with the ability to work under pressure while meeting corporate goals and objectives

·Strong communication skills

#RayzeBio, #LI-Onsite

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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