Manager, Quality Assurance Shop Floor

About the role

The Quality Assurance Shop Floor team oversees and partners with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This position is a people manager, leading a team of individual contributors in the Quality Assurance Shop Floor Organization.

Responsibilities

• Oversee performance of QA shop floor activities.
• Supervise Quality Assurance Shop Floor employees.
• Regularly spend time coaching and mentoring operators and QA personnel while on the manufacturing floor.
• Provide guidance and training on quality programs.
• Lead Quality on-the-floor oversight to Manufacturing/QC/Warehouse/Packout operations/Label Operations.
• Proactively identify risks/critical issues and drive mitigations and escalate to management as needed.
• Develop, review and/or approve temporary and non-routine procedure for event response.
• Periodically observe operations.
• Proactively identify risks and drive improvements.
• Provide quality oversight to non-routine maintenance work.
• Review and approve return to service plans.
• Clock in and coordinate and lead area walkthroughs to identify quality issues.
• Negotiate remediations and drive alignment of implementation plans.
• Act as a QA subject matter expert on behalf of the facility during audits and inspections.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform review of operational documentation including manufacturing batch records.

Requirements

• Previous Supervisory/Managerial Experience is preferred.
• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Built relationships internally within and with cross functional teams.
• Sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

Qualifications

• 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 relevant cGMP experience, preferably with 2+ years of QA Shop Floor experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Project management experience is preferred.
• Demonstrated experience with quality management systems.
• Demonstrated experience with electronic systems and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP).