Manager, Quality Assurance Shop Floor, Cell Therapy

Manager, Shop Floor QA, Cell Therapy

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.

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.

The Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at the Devens Cell Therapy Facility in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures, and Global Current Good Manufacturing Practices (cGMPs).

In the capacity of QA Shop Floor Support, the Manager, Shop Floor QA, Cell Therapy shall be responsible for handling Quality Assurance Shop Floor internal compliance and documentation tasks, routine communication to front line employees, and metrics / monitoring for key QASF processes. The incumbent will be considered a local process owner for core QASF systems / processes including but not limited to Alarm Review, Batch Record Review, and the GMP Walkthrough Program. The incumbent will be the steward for standard operating procedures, training, and managing relationships with key stakeholders.

They will be accountable to monitor and track process performance related to key Shop Floor quality assurance quality tasks and other operational tasks through data and analytics; to own, review or approve Floor Quality GxP records including but not limited to procedures, CAPAs, change controls, impact assessments, documentation, or deviations; and represent QASF at relevant governance forums. Additionally, the incumbent shall flex to support ad-hoc deviation approval or batch record review as requested by management. Effective communication, critical thinking, and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed.

This position reports to the Associate Director, Shop Floor Quality Assurance.

This is an individual contributor role working Monday to Friday.

Shifts Available : M - F, Standard Working Hours

Responsibilities

• Accountable for the performance / delivery of the QASF quality organization, including oversight of the "QA on-the-floor" systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks.
• Develop and implement, and continuously improve standard procedures and training for team-members related to quality systems.
• Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Quality Assurance staff and cross-functional partners and escalate to senior management as needed.
• Lead and / or represent QA in leadership, staff and tier meetings, governance forums or on project teams.
• Act as a QASF subject matter expert on behalf of the facility during audits and inspections.
• Provide timely QASF support to site compliance activities such as Change Control impact assessments, deviation impact assessments, and development of corresponding CAPAs.
• Advanced ability to synthesis information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner.
• Respond to complex / critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing.
• Serve as a subject matter expert supporting others to navigate the BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management.
• Provide leadership to ensure routine on-the-floor Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems.
• Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making.
• Champion a culture that embraces psychological and physical safety of employees in the work environment.
• Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence.
• Review and interpret the technical conclusions of a record / investigation and provide constructive feedback.
• Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge.
• Spend time coaching and mentoring operators and QASF staff while on the manufacturing floor.

Knowledge and Skills

Basic Requirements

Working Conditions

Physical / Mental Demands : Able to work near strong magnetic fields. Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, etc.).

Compensation Overview : $100,480 - $121,756

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.