Bristol Myers Squibb Manager, Quality Assurance Investigations, Cell Therapy in Devens, Massachusetts
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.
PURPOSE AND SCOPE OF POSITION:
The Quality Assurance Investigation Manager is responsible for the quality review and approval of manufacturing and laboratory investigations and product complaints at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. The role will provide Quality oversight and assure the quality of manufactured products are in compliance with all applicable regulations and guidelines.
Functional responsibilities include support and execution of root cause analysis and the determination of appropriate corrective/preventative actions as a result of investigation findings. This individual will also be responsible for maintenance and review of SOPs, and act as a Subject Matter Expert in quality investigations and product complaints. This individual may assist in preparing for and hosting of regulatory and customer audits.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements.
Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.
Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.
Demonstrated ability to develop and maintain strong business partner relationships internally and with cross-functional teams. Able to effectively work across functional groups and teams to ensure requirements are met.
Demonstrated background in core QMS concepts, QMS architecture, QMS improvement activities.
Demonstrated background of data-analytics for continuous improvement.
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
Requires direction to complete more complex tasks; completes routine tasks with little supervision. Confident in making decisions for minor issues and routinely recognizes Quality issues and solves problems.
Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Uses 5-WHY, Ishikawa Diagram and other Root Cause Analysis tools to structure and aid problem solving activities within a cross-functional team determining appropriate corrective/preventative actions as a result of investigation findings.
Demonstrated ability to develop and maintain strong business partner relationships internally and with cross-functional teams.
Is recognized as the Subject Matter Expert within the group for the investigation process and provides guidance to other employees in interpretation of complex data.
Able to recognize conflict and notify management with proposed recommendations for resolution.
Knowledge of applicable business systems including SAP, LIMS/Celabs, Maximo and Veeva Vault and Infinity.
DUTIES AND RESPONSIBILITIES
Participates in the startup of the Devens Cell Therapy facility including development of Standard Operating Procedures and business processes supporting quality assurance investigations and complaints.
Acts as QA lead to provide guidance to less experienced staff with atypical events during day to day operations.
Reviews and approves discrepancy reporting, investigations and corrections and actions associated with all areas of the manufacturing process including, incoming, manufacturing, laboratory, facility, and utility systems.
Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports.
Contributes to and supports the site team which prepares for, hosts, and responds to Health Authority inspection reviews and approvals of the facility and products
Collaborates with Disposition Lead for timely product release of material involved in quality investigations.
Collaborates with Compliance Lead to ensure documentation in QMS systems related to complaints and investigations follow appropriate guidelines.
Develops process improvement strategies and supports execution of site/team continuous improvement goals and projects.
Identifies and reports any EHS, Quality or Compliance concerns and takes immediate corrective action or escalation as required
Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives.
Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that enhances unit performance.
EDUCATION AND EXPERIENCE
B.S. in a life or physical science related discipline.
Minimum of 6 years of pharmaceutical experience or related GMP industry.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol Myers Squibb
Req Number: R1552234
Updated: 2022-01-26 04:04:42.929 UTC
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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