Lead, QA Tech Ops Investigations

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.

This role is a Lead in the Devens Quality Assurance (QA) Technical Operations function. The role primarily supports the site-wide Investigations and Corrective Action/Preventative Action (CAPA) programs, inclusive of commercial drug substance manufacturing, clinical drug substance manufacturing, GMP cell banking, and Quality Control (QC) lab operations.

• Works cross-functionally with lead investigators, subject matter experts, and supervisors within the GMP functions to support investigations and CAPAs at the Devens site
• Provides oversight and guidance for event review, impact assessment, root cause analysis and CAPA planning activities
• Performs review and approval of investigations, CAPAs, and effectiveness reviews in the Quality Management System
• Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products. Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams.
• Supports trending, metrics, and routine assessment of site-wide Investigations and CAPA programs
• Provides for strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.

Key Core behavioral indicators for this role include: Participates in the creation of a team-based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals. Demonstrates appropriate examples of compliance behaviors and attitudes. A high degree of accountability and matrix leadership is critical.

Knowledge and Skill set Requisites:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required.
• A minimum of 6 years relevant experience with a minimum of 4 years in a regulated environment.
• Knowledge of Investigations and/or CAPAs is highly desirable.
• Knowledge of biotech bulk and finished product manufacturing, and/or analytical testing, is highly desirable.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva, and electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.
• Demonstrated leadership, interpersonal, communication, and motivation skills.
• Excellent writing and oral communication skills are required.
• Previous work responsibility, which required a high degree of attention to detail.
• Well practiced in exercising sound judgment in decision-making.
• Past experience where one was required to work in a team based environment with a diverse group of people.

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.