Manager Quality Assurance Shop Floor Cell Therapy

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Bristol Myers Squibb
Manager, Quality Assurance Shop Floor Cell Therapy
in
Summit
New Jersey
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The Manager of QA Shop Floor is responsible for providing management for the QA shop floor program in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures and Global cGMP. Responsible for managing the activities of the shop floor team to ensure manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Must have 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 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 manage development of technical or scientific initiatives and activities by interdisciplinary teams.
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 patterns and trends in reported data and communicate strategic solutions to stakeholder's cross-functionally.
Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation.
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.
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. Develops procedures.
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.
Education and Experience:
Relevant college or university degree required.
Minimum 7 years of related Quality Assurance experience , with at least 3 years in a GMP, Aseptic Manufacturing environment, are required.
Minimum of 3 years of Managerial/Leadership experience required
Equivalent combination of education and experience acceptable.
DUTIES AND RESPONSIBILITIES:
Supervise and manage the QA shop floor program and group located at the Summit S12, NJ facility.
Provide leadership and build an exceptional team to manage the QA shop floor program, including hiring, mentoring and developing personnel
Ensure manufacturing compliance with applicable procedures and batch records.
Perform real time review of manufacturing batch records.
Review manufacturing shop floor documentation.
Issue production batch records and product labels to Operations.
Ensures control of systems, processes and product through supporting review and approval of change notices and change control.
Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Must be skilled in planning and organizing, decision-making, and building relationships.
Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
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.
Able to effectively multi-task.
WORKING CONDITIONS (US Only):
Work is performed in a combination of manufacturing and office environments, with manufacturing and standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 50%of the time, in a mixed environment of office areas and cleanroom suites (in cleanroom gowning). Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
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 the resources to pursue their goals, both at work and in their personal lives.
Company:****
Req Number:
R1522734_EN
Updated:
2020-03-13 00:00:00.000 UTC
Location:
Summit,New Jersey
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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