Shift: Wednesday–Saturday, Onsite Night Shift, 6:00 p.m.–4:30 a.m.
Responsibilities:
- Implement/manage site Label Operations at S12 Summit West (Summit, NJ) per BMS policies/standards/procedures and Global cGMPs.
- Supervise label control activities for Cell Therapy Development and Operations (CTDO); lead label management and align with global/regional regulatory requirements.
- Develop/maintain a GMP-compliant clinical and commercial label issuance and control process; ensure continuous improvement.
- Oversee daily activities; act as site lead for clinical/commercial label management system implementation initiatives; support projects within timelines.
- Ensure timely issuance of in-process and final product labels; coordinate deliverables for launches/market and quality initiatives.
- Lead SOP creation/review/update and GMP documentation/batch record archival; perform gap assessments and recommend solutions.
- Maintain quality metrics; collaborate on corrective actions for quality system issues.
- On-board requirements/training for new staff; coach/mentor team (training, discipline, problem solving, professional growth).
- Support electronic label issuance/control systems.
- Perform supplemental investigations/projects as required by management.
Qualifications & Skills:
- Advanced GMP, Quality, compliance, and risk management knowledge.
- Ability to interpret issues and communicate clearly; author and critically review reports; apply Quality Risk Management.
- Action-oriented, customer-focused; strong decision-making, problem solving, planning, resource allocation, conflict management.
- Lead teams/cross-functional projects; coach talent; independent mindset and tenacity.
- Proficient with PC/Microsoft Office; minimal direction; manage experienced professionals.
Minimum Requirements:
- B.S. degree (or equivalent education/experience); 5+ years relevant experience; 2+ years leadership.
Compensation/Benefits (if eligible): $103,560–$125,495; health/dental/vision, wellbeing support, 401(k), disability/life/other insurance, and paid time off (details vary by eligibility).