Manager, Quality Assurance Shop Floor, Cell Therapy

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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