Lead QA Automation

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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.

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.

This role is a Lead in the Devens Quality Assurance (QA) Technical Operations function. The role primarily supports the Quality Control (QC) lab operations to drive compliance and quality across QC operations as it relates to clinical and commercial drug substance manufacturing, method validation, and stability testing.


Performs review and approval of standard operating procedures, work instructions, and protocols related to QC laboratory operations
Works with the QA Technical Operations team to provide oversight and guidance for QC event review, impact assessment, root cause analysis, CAPA planning, and validation activities as needed
Works cross-functionally with QC leadership, analysts, and supervisors to drive compliance, quality and continuous improvement across QC operations
Works cross-functionally to support relevant trending and metrics of QC laboratory methods
Provides for strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.
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.


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 Quality Control testing and/or analytical methods/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.

Company: Bristol-Myers Squibb

Req Number: R1526567_EN

Updated: 2020-06-30 00:00:00.000 UTC

Location: Devens,Massachusetts

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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