Senior Manager, GCP QMS Integration

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.

 Key competencies required:

• Bachelor’s degree with 10-12 years’ experience, Master’s degree with 8-10 years’ experience or PhD with 6-8 years’ experience working in a pharmaceutical or highly regulated environment.

• Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations.

• Demonstrated ability to drive organizational change while balancing priorities utilizing strong organizational skills

• Exemplary leadership skills as demonstrated by the ability to manage individuals and teams towards meeting goals

• Ability to drive consensus, drive performance and to lead strategically.

• Demonstrated success in managing project, team effectiveness, facilitation and presentation skills

• Demonstrated knowledge of FDA regulations and ICH guidelines applicable to GXP. FDA regulations and ICH guidelines include, but are not limited to, the following:

• 21 CRF Parts 11, 58, 111, 210, 211, 610 and 820  ICH Q7, Q8, Q9, and Q10

• High level of competency in PD writing including the appropriate use of grammar, syntax and organization of ideas

• Knowledge of project management concepts and strategies

• Knowledge of requirements for development, use and maintenance of controlled procedural documents

• Demonstrated ability to resolve complex issues and differences in a creative, constructive and diplomatic manner

• Demonstrated ability to work independently and mentor team members

• Demonstrated ability to maintain a high level of productivity, accountability and energy

• Proven teambuilding skills and an ability to foster partnerships across projects and multidisciplinary teams

• Demonstrated ability to follow up on open issues and