Manager, Shop Floor Qa

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.
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.
PURPOSE AND SCOPE OF POSITION:
The Manager of QA Shop Floor Operations is responsible for providing management for the QA Shop Floor program in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Responsible for managing the activities of the Shop Floor team to ensure vector manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks and working with operations to resolve manufacturing issues.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes.
• Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
• Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Must be able to direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Must possess an independent mindset.
• Must require moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Must be confident in making decisions for non-routine issues.
• Must have the ability to develop procedures

• Must have intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Must be able to understand continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Manages conflict and issues with internal and external customers. Demonstrates

• negotiation skills in internal and external cross-functional teams. Demonstrates coaching skills.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.

• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills

DUTIES AND RESPONSIBILITIES:

• Supervise and manage the QA Shop Floor program and group located at the Vector Manufacturing Facility.

• Provide leadership and build an exceptional team to manage the QA Shop Floor program, including hiring, mentoring, and developing personnel.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing Shop Floor documentation.
• Issue production batch records and product labels to Operations.

• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Must be flexible for shift hour changes to support manufacturing.

EDUCATION AND EXPERIENCE (As Applicable):

• A Bachelor's degree with 5+ years of relevant work experience demonstrating leadership capabilities, or an equivalent combination of education and experience may be considered.
• Candidate must be familiar with and be able to interpret relevant regulations, regulatory agency inspection expectations e.g., FDA, EMEA, Health Canada, etc.

WORKING CONDITIONS: (US Only):
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 25% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. The incumbent will also be required to gown to access classified manufacturing areas. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
#BMSCart, #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 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 Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.