Quality Assurance Investigations Manager

5 days ago

Devens, Massachusetts, United States Bristol-Myers Squibb Full time
Job Summary

The Quality Assurance Investigations Manager at Bristol-Myers Squibb will be responsible for the quality review and approval of manufacturing and laboratory investigations and product complaints. This role will provide Quality oversight and assure the quality of manufactured products are in compliance with all applicable regulations and guidelines.

Key Responsibilities

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.
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.

Requirements

B.S. in a life or physical science related discipline (equivalent industry experience will also be considered).
Minimum of 6 years of pharmaceutical experience or related GMP industry.
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 is desirable.

Working Conditions

Must be able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.).

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