Manager, Label Operations

Job 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. Functional responsibilities include supervision of all label control activities for Cell Therapy Development and Operations (CTDO); responsible for developing and maintaining a GMP compliant clinical and commercial label issuance and control process.

The Label Operations organization is responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives. This organization supports the S12 facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

• Sunday - Wednesday, Onsite Night Shift, 6 p.m.
  
  - 4:30 a.m.

• The Label Operations manager will lead team to ensure Label Management and align with Global and Regional Regulatory requirements.
• Manage and motivate team members, build trust and cultivate a collaborative environment.
• Oversee team responsibilities and maintain a state of compliance.
• Work proactively to identify and address any label control compliance issues.
• Oversees, supervises, coordinates and prioritizes daily activities of the Label Operations team located at Summit, NJ S12 facility.
• Act as site lead for clinical and commercial label management related system implementation initiatives. Fully support projects within project timelines.
• Assures job objectives are met on a timely basis.
• Assures timely issuance of clinical and commercial in-process and final product labels for labeling operations.
• Coordinates and prioritizes project deliverables to support new drug product launches, new market and other quality management activities as assigned.
• Creates employee development plans, and oversight of functional area to assure adequate staffing.
• Coach and mentor subordinates in the areas of training, disciplinary action, problem solving, and professional growth.
• Provide support for activities using the electronic label issuance and control systems.
• Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs while managing archival of batch records and GMP documentation for the site.
• Perform gap assessments to identify process deficiencies, provide reports to document detailed findings and recommend potential solutions.
• Develops and maintains quality metrics to monitor compliance.
• Collaborates with stakeholders to develop appropriate actions to resolve quality system issues.
• Responsible for developing, managing, and on-boarding requirement for new staff within label control.
• Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
• Performs supplemental investigations/projects as required by management.

• Must have advanced GMP, Quality, compliance and risk management knowledge.
• Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
• Provide guidance to other employees in the interpretation of compliance and technical/scientific issues across most of the job function. Develop employees and coach them to bridge knowledge gaps.
• Must have strong authorship and able to critically review reports while effectively providing input and expressing Quality Risk management principles.
• Must be action-oriented, customer-focused and skilled in decision‑making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking.
• Must be skilled in coaching others, talent selection, developing others, decision‑making, building relationships, innovation management, and resource allocation.
• Must possess an independent mindset and tenacity.
• Leads teams and cross‑functional…