QA Deviation Reviewer, Approver, Specialist

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.

About Bristol-Myers Squibb

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.

PURPOSE AND SCOPE OF POSITION:
This role will be responsible for providing quality oversight for site manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of SOPs and methods, providing compliance oversight for Manufacturing Operations and QC laboratories; ensuring accurate and timely review of manufacturing and laboratory investigations; performing analysis on quality indicating data and identifying any trends and providing oversight for data integrity initiatives for the site.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Must have GMP, Quality, and risk management knowledge.
• 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 and reports, 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 stakeholders cross-functionally.
• Requires moderate direction to complete tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; authority to make daily decisions that impact their team.
• Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Routinely recognizes and resolves quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
• Able to 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.
• 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.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, coaching others, and analytical thinking.
• Consults management for advice on complex issues.
• Work is self-directed.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
• Understands fundamental scientific problems.
• Able to write and review reports with clarity and brevity.
• Able to produce data reports with precision.

Education and Experience:

B.S. degree required, minimum of 5 years of experience in the pharmaceutical or related industry.

DUTIES AND RESPONSIBILITIES:
• Supports all activities for the Quality Operations group.
• Provide quality oversight of Manufacturing Operations, QC Chemistry and QC Microbiology.
• Work with manufacturing and laboratory management to ensure activities comply with global regulatory requirements.
• Ensure procedures are adequate to review and confirm appropriateness of raw data.
• Review/approval of manufacturing and laboratory deviations.
• Review site change controls and ensure appropriate requirements are identified and completed for implementation.
• Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
• Ensure control of systems, processes and product through supporting review and approval of change notices and change control.
• Ensure site is compliant with global and regulatory data governance and data integrity requirements.
• Establishes and maintains procedures to ensure data integrity is maintained and procedures/processes are compliant.
• Assess global standards/policies and emerging regulations.
• Ensure the site stability program meets global and regulatory requirements.

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.