QA Compliance Specialist

Profile

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.

The position reports to the New Brunswick Compliance and Quality Systems Lead, with job responsibilities that include but are not limited to:


Risk Assessment facilitation and maintenance of risk registers for all PD sites

Training support to liaise with the Product Development Operations group

Support Enterprise Systems such as DocMan, PDHQ, SuccessFactors, Infinity either functioning as an Administrator or Content Manager; act as point of contact and SME for any updates on Enterprise systems

Track, trend and report quality metrics to senior management through Key Performance Indicators (KPIs)

Review documents related to Quality Systems such as SOPs, Deviations and CAPAs.

Support and participate in internal audits of Product Development.

Support routine self inspection of PD sites

Participate in Investigation Excellence initiatives


Adherence to BMS core behaviors


Knowledge of science generally attained through studies resulting in a B.S., in chemistry, pharmacy or biology or a related pharmaceutical science.

Minimum of 5-10 years’ experience in pharmaceutical quality.

Knowledge of ELMS and other Enterprise Systems (i.e. DocMan, PDHQ, SuccessFactors) is highly desirable.

Proficiency with conducting root cause analysis and risk facilitation

Proficiency with MS Office Suite.

Demonstrated proficiency in interpretation of FDA and EMA cGMP regulations as they apply to clinical supplies

Experience in R&D environment is highly desirable.

Demonstrated interpersonal, communication, and motivation skills.


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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

Company info

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