Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Senior Manager provides management of activities for site Quality Operations in accordance with BMS policies, standards, procedures and global cGMPs. Responsible for supervising the activities of the Quality Assurance Operations Cell Therapy Development and Operations (CTDO) Investigations group at S12; ensuring accurate and timely management and review of S12 investigations and CAPA; providing guidance for identifying any trends noted during review of the manufacturing and laboratory documentation; providing S12 support for trending of quality compliance metrics. Managing 5 direct reports. 2nd Shift - Monday to Friday, 12 noon to 8 p.m.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Must have 9+ years of experience in GMP, Quality and in-depth risk management knowledge.

* Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.

Must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.

Must be able to recognize and group technical/scientific attributes and drive science based decisions in most technical areas and to a deeper level in the specific job function.

Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.

Must have previous experience Leading 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.

Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.

Routinely recognizes and resolves Quality issues; informs upper management of proposed solutions. Seeks management guidance on complex issues.

Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.

Scope of problem solving includes direct reports. Critically assesses project(s) and allocates resources to efficiently achieve goals. Implements solutions independently. Develops employees.

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.

Manages conflict and issues with internal and external customers. Demonstrates negotiation skills in internal and external cross-functional teams. Demonstrates coaching skills.

DUTIES AND RESPONSIBILITIES:

Supervises and manages daily activities of the QA Operations Investigations group located at Summit-S12, NJ facility. Assures job objectives are met on a timely basis.

Leads QA team members in the deviation investigation process.

Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.

Ensures control of systems, processes and product through supporting review and approval of change notices and change control.

Updates and procures approval of job descriptions for department personnel. Performs and oversees the training of personnel. Effectively hires, develops, counsels, manages and motivates staff. Writes and administers performance appraisals for department personnel.

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.

Supports site teams to compile the Annual Product Review/Global Product Quality Review Summary for BMS product manufactured.

Supports the site internal auditing program assuring CAPAs are completed in a timely manner.

Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.

Performs supplemental investigations/projects as required by senior management.

If you want to challenge yourself, accelerate your career, and give new hope to patients, theres no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. 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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.