Manager, Label Operations

About the role

Working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department—from optimizing a production line to the latest breakthroughs in cell therapy. This role within the Cell Therapy team offers the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams, transforming the lives of patients and your career.

Bristol Myers Squibb recognizes the importance of balance and flexibility, offering a wide variety of competitive benefits, services, and programs that provide resources to pursue goals both at work and in personal life.

The Label Operations Manager at the S12 Cell Therapy manufacturing facility is responsible for implementing and managing site Label Operations activities at S12 Summit West (Summit, NJ) in accordance with BMS policies, standards, procedures, and Global cGMPs. This role oversees all label control activities for Cell Therapy Development and Operations (CTDO) and is responsible for developing and maintaining a GMP-compliant clinical and commercial label issuance and control process.

Responsibilities

• Lead the Label Operations team to ensure Label Management aligns with Global and Regional Regulatory requirements.
• Manage and motivate team members, building trust and cultivating a collaborative environment.
• Oversee team responsibilities and maintain a state of compliance.
• Proactively identify and address any label control compliance issues.
• Supervise, coordinate, and prioritize daily activities of the Label Operations team at the Summit, NJ S12 facility.
• Act as site lead for clinical and commercial label management-related system implementation initiatives.
• Support projects within project timelines and ensure job objectives are met on time.
• Ensure timely issuance of clinical and commercial in-process and final product labels for labeling operations.
• Coordinate and prioritize project deliverables to support new drug product launches, new markets, and other quality management activities.
• Create employee development plans and ensure adequate staffing for the functional area.
• Coach and mentor subordinates in training, disciplinary action, problem-solving, and professional growth.
• Provide support for activities using electronic label issuance and control systems.
• Write, review, and update SOPs, managing archival of batch records and GMP documentation for the site.
• Perform gap assessments to identify process deficiencies, document findings, and recommend solutions.
• Develop and maintain quality metrics to monitor compliance.
• Collaborate with stakeholders to resolve quality system issues.
• Develop, manage, and onboard new staff within label control.
• Maintain current knowledge of industry standards as they apply to cGMPs and global regulatory guidelines.
• Perform supplemental investigations and projects as required by management.

Requirements

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

Skills

• Advanced GMP, Quality, compliance, and risk management knowledge.
• Ability to interpret problems and prepare clear, productive communication for management and the team.
• Provide guidance on compliance and technical/scientific issues across the job function.
• Strong authorship and critical review of reports, applying Quality Risk management principles.
• Action-oriented, customer-focused, and skilled in decision-making, relationship-building, problem-solving, conflict management, planning, organizing, resource allocation, and analytical thinking.
• Skilled in coaching, talent selection, developing others, innovation management, and resource allocation.
• Independent mindset and tenacity.
• Leads teams and cross-functional project teams, driving performance and results.
• Contributes to departmental performance and quality initiatives, conceptualizing the impact of quality initiatives across teams.
• Proficiency with PC-based office computers and standard Microsoft Office applications.
• Minimal direction required to complete tasks; consults with manager for decisions outside established processes.
• Effectively communicates internally and with cross-functional teams, representing the department in internal and external teams.
• Recognizes and resolves quality issues, informing management of proposed solutions and developing procedures.

Working Conditions

• Work is performed in a typical office environment with standard office equipment.
• Generally seated but may require standing and walking for up to 10% of the time.
• Lighting and temperature are adequate; no abnormal conditions caused by noise, dust, etc.

Schedule

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

Pay

Summit West - NJ - US: $103,560 - $125,495 starting compensation range for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate accounts for required skills, job location, work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits:
  • Paid Time Off for US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio).
  • Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year’s Day.

All global employees (full and part-time) actively employed at and paid directly by BMS at the end of the calendar year are eligible for the Global Shutdown.