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. Shift Available: - Wednesday - Saturday, Onsite Night Shift, 6 p.m. - 4:30 a.m. Responsibilities: - 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. Knowledge & Skills: - 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 project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of quality initiatives in terms of cross-functional teams; emerging as a leader contributing to BMS culture and values. - Demonstrated proficiency with PC-based office computers and standard Microsoft Office applications. - Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with manager for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team. - Effectively communicates internally within the function and with internal and external cross-functional teams. Interacts with internal and external cross-functional teams. Represents department in internal and external cross-functional teams. - Routinely recognizes and resolves quality issues informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures. Minimum 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. Working Conditions: - Work is performed in a typical office environment, with standard office equipment available and used. - Work is generally performed seated but may require standing and walking for up to 10% of the time. - Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. BMSCART, #LI-Onsite If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Summit West - NJ - US: $103,560 - $125,495 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: - 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 include: Paid Time Off - 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 employees) - 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 Based on eligibility*, additional time off for employees 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 Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.