Manager, QA Investigations and CAPA

Working with UsChallenging. 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.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 .At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.As the Manager, QA Investigations and CAPA, you will be responsible for the deviation investigation approvals, and CAPA approvals and ensure adherence to applicable GMP regulations and BMS policies and procedures. Incumbent will also provide consistent direction and ensure timely completion of their deviation investigations and CAPAs to ensure success during regulatory inspections.Shift Available:

Monday - Friday, 12 p.m. - 8:30 p.m. Onsite

Responsibilities:

Review and approve complex investigations/ CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems.

Author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program.

Ensure the corrective/ preventive actions are robust and adequately address the root cause.

May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions.

Participate in monthly COP forum.

Lead or participate on globally driven sub teams to drive investigation excellence and improvements.

Drive deployment of effective deviation processes within representative site/function.

Coach employees on aspects of investigations.

Resolve investigational process or system issues.

Ensure appropriate issues are cascaded to global team and liaise with global team on routine basis.

Champion for culture of quality within the deviation program.

Proactively monitor metrics and take relevant actions (including work prioritization) to ensure that disposition timelines and other targets are met.

Identifies improvement opportunities and drives execution of site/team continuous improvement goals and projects.

Support internal and external inspections as required.

May present individual topics during audits as needed.

Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams.

Support integration of newer team members

Acts as Subject Matter Expert of the deviations program and provides guidance/ coaching to less experienced staff with atypical events during day-to-day operations.

Lead meetings and represent function at cross functional and network meetings.

Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.

Knowledge & Skills:

Demonstrated experience with electronic system and databases.

Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.

Deviations Program Subject Matter Expert.

Ability to work in a fast-paced team environment and lead peers through changing priorities.

Ability to think strategically, meet deadlines and support work prioritization.

Able to independently work across functional groups and teams to ensure requirements are met.

Ability to motivate and foster a positive team environment.

Confident in making decisions, able to anticipate Quality issues and proactively solve problems.

Curiosity and ability to think critically to create innovative solutions.

Basic Requirements:

Bachelor's degree in STEM field preferred. High School diploma/ Associate's degree with equivalent combination of education and work experience may be considered.

6+ years of experience in a regulated industry

A minimum of 2 years of deviation experience.

Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Preferred Requirements:

Quality experience.

Leadership skills.

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 CareersWith 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 an inclusive culture, promoting diversity 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 ProtocolBMS 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 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 [email protected] . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.Company: Bristol-Myers SquibbReq Number: R1580676Updated: 2024-05-16 01:57:24.331 UTCLocation: Summit-NJBristol 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.