Manager Quality Systems, Investigations and CAPA

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.

Position Summary

The Manager, Quality Systems is responsible for supporting the ownership and oversight of Devens Cell Therapy quality systems, such as CAPA, Investigations per established local and global standards. This position supports the overall compliance and performance of Devens Cell Therapy Quality Systems Management as it applies to the site level, including periodic assessments of process performance and continuous improvement opportunities

Duties/Responsibilities

• Review and approve complex site quality system deliverables and risk assessments associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.
• Ensure quality system deliverables are robust and adequately address requirements and risks, by providing oversight and rubric reviews, as applicable.
• Support the administration and maintenance of quality systems such as CAPA, Investigations, including metrics reporting and analysis, stakeholder communication, and governance meeting facilitation, as needed.
• Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.
• Lead meetings and represent function at cross functional and network meetings.
• Identify improvement opportunities and drive team continuous improvement goals and projects.
• Support internal and external inspections.
• May act as subject matter expert and present quality system program overviews and related topics during audits.
• Maintain compliance with assigned learning plan. 
• Support integration of newer team members and provide guidance and coaching to users of the electronic QMS, CAPA, and Investigations quality systems, as required.
• Lead meetings and represent function at cross functional meetings. Share data/ knowledge within and across teams. Build & maintain strong relationships with partner functions.

Reporting Relationship

This position is within the Devens Cell Therapy Compliance and Quality Systems Organization, reporting to the Director of Compliance and Quality Systems Management

Qualifications

Specific Knowledge, Skills, Abilities:

• Ability to research, understand, interpret, and apply internal policies and regulatory guidelines
• Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications
• Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on impact assessments and proposed change control actions
• Ability to critically review reports, interpret results and assess and challenge technical conclusions consistent with quality risk management principles
• Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy
• Ability to work in a fast-paced team environment and changing priorities
• Detail oriented and task focused with ability to meet deadlines and prioritize work
• Able to independently work across and influence cross-functional groups to ensure requirements are met
• Ability to motivate and foster a positive team environment
• Confident in making decisions for complex issues and able to recognize Quality issues and solve problems
• Curious and ability to think critically to create innovative solutions

Education/Experience/ Licenses/Certifications:

• Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.
• 6+ years of experience in a regulated industry, preferably with 2+ year of quality system experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. 
• Demonstrated proficiency with electronic system and databases

The starting compensation for this job is a range from $115,110   - $139,500  plus incentive cash and stock opportunities (based on eligibility). 

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. 
Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

BMSCART, #LI-Onsite

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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.

Devens - MA - US: $107,100 - $129,780

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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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