Bristol Myers Squibb Lead, QA Automation 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.
This role is a Lead in the Devens Quality Assurance (QA) Technical Operations function. The role primarily supports the Automation and Information Technology function to drive compliance and quality across automation and computerized systems as it relates to clinical and commercial drug substance manufacturing.
Performs review and approval of standard operating procedures, work instructions, and protocols related to automation and computerized systems
Works with the QA Technical Operations team to provide oversight and guidance for automation event review, impact assessment, root cause analysis, CAPA planning, and validation activities as needed
Works cross-functionally with Automation and Information Technology leadership and team members to drive compliance, quality and continuous improvement across the Automation and Information Technology function
Reviews and approves automation and computerized system changes to ensure compliance in Quality Management Systems
Manages site wide forum(s) and trending for the review and assessment of proposed automation and computerized system changes to ensure compliance and risk management.
Drives continuous improvement in automation change workflows to ensure a high degree of compliance while maximizing efficiency
Supports site-wide Data Integrity initiatives
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 computerized systems, automation, validation and/or software release testing is highly desirable.
Knowledge of electronic systems including any of the following: DeltaV, Syncade, 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-us
Updated: 2020-09-25 01:21:19.402 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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