Bristol Myers Squibb Sr. Specialist, Compliance and Methodologies in Devens, Massachusetts
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us .
At BMS, digital innovation and Information Technology are central to our vision of transforming patients’ lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology in a manner compliant with a high level of quality and Health Authority compliance requirements. We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care.
This position marries the technical aspects of drug manufacturing with compliance and quality requirements, and is fundamental to achieving on-time and high-quality product for our patients.
If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!
Supports the Digital Plant computer system validation process; generates computer system validation documents (such as plans, reports, protocols, and test scripts) and guides Digital Plant personnel in development/execution of such documents.
Works actively with other groups to generate well-developed computer system validation deliverables.
Assists groups with data integrity analysis and assessment exercises.
Leads validation and, where necessary, testing, activities as required by computer system validation processes.
Supports Digital Plant audit activities, including performing research, generating auditor presentations and presenting to auditors when needed; assists in researching and generating responses to audit observations.
Researches existing and new business, IT, and Automation processes, and develops procedural and guidance documents to describe the processes.
Develop understanding of BMS policies and procedures related to computer system validation and IT compliance.
Develops and presents training on compliance-related processes.
Continuously remains alert for and looks for process improvement / simplification opportunities.
Researches compliance and IT Quality develops in the industry and Health Authorities to identify and address new areas of interest; develops papers and presentations to support promulgation of such developments to the Digital Plant and other groups.
Supports the Digital Plant training program, in managing metrics and looking for improvements to the process and to training offerings.
Generates standards, guidance documents, and templates to improve other processes performed under Digital Plant processes.
Qualifications & Experience
The successful candidate will possess a minimum of a Bachelor’s degree in a science or Engineering field with at least 2 years of experience working in the pharmaceutical industry, preferably in the biotechnology sector.
A successful candidate will have basic knowledge and experience with manufacturing execution systems and the manufacturing process; experience and/or substantial understanding of process control principles and common system vendors’ available products would be a plus
A basic understanding of quality principles, system development lifecycles, and quality assurance methodologies is needed.
A strong understanding of Information Technology and Software concepts and how these relate to compliance, quality, and data integrity is required; skills in software development (including code development), SQL, and basic database concepts would be a plus.
Detailed knowledge of Microsoft Office products (including Word, Excel, and PowerPoint: “Access” and “Project” would be a plus) is required.
Ability to work in a diverse work environment, manage multiple priorities, and at times, be self-directed.
Excellent written and communication skill are required.
Candidate must have a flexible and creative work style with a goal of attaining excellence.
The candidate will require a good level of attention to detail while maintaining a view of the “big picture”.
Collaborates and works with stakeholders to meet requests.
Excellent written and communication skill are required.
Why You Should Apply
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.
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 accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to email@example.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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: R1566836
Updated: 2023-05-29 02:48:58.544 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.
Bristol Myers Squibb
- Bristol Myers Squibb Jobs