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Manager, Documentation and Training

3 months ago


New Brunswick, United States Bristol-Myers Squibb Full time

**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 rich in diversity. Take your career farther than you thought possible.

**Manager, Documentation and Training**

**ASO- GMP Laboratory Systems**

**Roles & Responsibilities**:

- Write and revise GMP procedures (standard operating procedures (SOPs), work instructions, job-aids, etc.) for GMP laboratory operation and instruments.
- Document Coordinator role in electronic document management systems (EDMS) to manage all aspects of documentation compliance program.
- Prepare procedure periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.
- Work independently but recognize need to consult stake holders and keep them informed of progress.
- Coordinate/perform training impact assessments of applicable procedures.
- Support training program to ensure GMP laboratory and support personnel are trained on required procedures.
- Manage training item assignments, curricula and training reports to ensure on time metrics.

**Experience & Qualifications**:

- BS in technical field with minimum 5 years of experience in a regulated GMP environment or medical device industry writing and reviewing standard operating procedures.
- Experience using an electronic documentation management system (EDMS) is a must.
- Experience with Veeva Vault and Success Factors systems a plus.
- Excellent organization skills and ability to manage multiple projects.
- Excellent verbal communication, technical writing skills, and close attention to detail.
- Ability to work with matrixed teams, and negotiate or influence solutions without direct authority.
- A self-starter with an ability to manage electronic systems with mínimal training and supervision.

**Why You Should Apply**

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.

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**

BMS has a diverse 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 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.