Manager, Label Operations

Position Overview

The Label Operations Manager at the S12 Cell Therapy manufacturing facility is responsible for implementing and managing the site Label Operations activities at S12 Summit West (Summit, NJ) in accordance with BMS policies, standards, procedures and Global cGMPs. The role includes supervision of all label control activities for Cell Therapy Development and Operations (CTDO), development and maintenance of a GMP compliant clinical and commercial label issuance and control process, and continuous improvement of the label control process to ensure patient safety and regulatory compliance.

Wednesday – Saturday, Onsite Night Shift, 6 p.m. – 4:30 a.m.

• Lead the Label Operations team to align with global and regional regulatory requirements.
• Manage and motivate team members, build trust, and cultivate a collaborative environment.
• Oversee team responsibilities and maintain compliance with all label control requirements.
• Identify and address label control compliance issues proactively.
• Coordinate and prioritize daily activities of the Label Operations team.
• Act as site lead for clinical and commercial label management system implementation initiatives.
• Support projects within defined timelines and ensure job objectives are met timely.
• Ensure timely issuance of clinical and commercial in‑process and final product labels.
• Coordinate project deliverables for new drug product launches and other quality management activities.
• Develop employee development plans and oversee staffing adequacy.
• Coach and mentor subordinates in training, disciplinary action, problem‑solving, and professional growth.
• Provide support for activities using electronic label issuance and control systems.
• Ensure standard operating procedures (SOPs) related to label control are defined, reviewed, and updated; manage archival of batch records and GMP documentation.
• Perform gap assessments to identify process deficiencies, document findings, and recommend solutions.
• Develop and maintain quality metrics to monitor compliance.
• Collaborate with stakeholders to develop actions to resolve quality system issues.
• Oversee development, management, and onboarding of new staff within label control.
• Maintain current knowledge of industry standards, cGMPs, and global regulatory guidelines.
• Perform supplemental investigations or projects as required by management.

• Advanced knowledge of GMP, quality, compliance, and risk management.
• Strong analytical and decision‑making skills with a focus on customer service.
• Ability to interpret technical and scientific issues and communicate effectively to management and group.
• Proficient in authoring and critically reviewing reports, applying quality risk management principles.
• Experience coaching, developing, and mentoring employees.
• Excellent relationship‑building, conflict management, and resource allocation abilities.
• Independent mindset, tenacity, and leadership of cross‑functional project teams.
• Proficiency with PC‑based office computers and Microsoft Office applications.
• Strong communication skills internally and externally across cross‑functional teams.

• B.S. Degree required; equivalent combination of education and experience may be considered.
• Minimum 5 years relevant work experience; minimum 2 years of leadership experience.

Work is performed in a typical office environment with standard office equipment. The role is generally performed seated with sitting and standing for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise or dust.

Equal employment opportunity statement is available on the BMS careers site.