Manager, Label Operations

About the role

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.

Responsibilities

• 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.
• Supports projects within project timelines, assures job objectives are met on a timely basis, and assures timely issuance of clinical and commercial in-process and final product labels.
• 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 oversees functional area to assure adequate staffing.
• Coaches and mentors subordinates in the areas of training, disciplinary action, problem solving, and professional growth.
• Provides 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.
• Performs 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.
• Develops and manages, and on-boards 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.

Requirements

• B.S. Degree required. Equivalent combination of education and experience will be considered.
• Minimum 5 years relevant work experience.
• Minimum 2 years of leadership experience.

Skills

• Advanced GMP, Quality, compliance and risk management knowledge.
• Ability to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.
• 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.
• Authorship and ability to critically review reports while effectively providing input and expressing Quality Risk management principles.
• Action-oriented, customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, and analytical thinking.
• Leadership skills, including coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.
• Independent mindset and tenacity.
• Experience leading teams and cross-functional project teams and driving team performance and results.

Benefits

At Bristol Myers Squibb, we offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Pay

$103,560 - $125,495

Schedule

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