Manager, Quality Assurance Shop Floor - Summit West NJ

Quality Assurance Shop Floor Manager

The Quality Assurance Shop Floor team is responsible for 24x7 quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, Label Operations and Warehouse Operations. This position will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This position is a people manager position, leading a team of individual contributors in the Quality Assurance Shop Floor Organization.

Wednesday to Saturday - 12-hour shift (every other Wed off) 5 a.m. to 5:30 p.m.

Duties/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.
• 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.
• 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.
• For markets requiring an Authorized Person (AP) release to be performed by Summit, act as designated AP performing Certification/Release for Supply in accordance with the PIC/S Guide to GMP (including Annex 16) and any local market requirements e.g. Australian Therapeutic Goods Administration (TGA) requirements, including the Therapeutic Goods Act 1989 and associated GMP principles.
• Perform verification and reconciliation of issued drug product labels.