Bristol-Myers Squibb Company

Laboratory Compliance Manager

Location
New Brunswick, NJ, United States
Posted
Jun 22, 2019
Ref
R1513688
Required Education
Bachelors Degree
Position Type
Full time
Job description

Advice department on the design of testing laboratory processes and activities for enhanced compliance.

Accelerate implementation of practice changes in testing laboratories brought by procedure revisions and change management.

Apply GMP regulations in an environment that bridges development and commercial manufacturing of active ingredient and medicinal products.

Function as expert in laboratory procedures through understanding of their application and authoring.

Conduct laboratory investigations and design corrective/preventive actions and grow the laboratory investigator community through measurement. Conduct efforts that build investigation expertise.

Drive audit readiness of GMP laboratories.

Perform as a department leader in support of the Quality Management System and Quality Risk Management program.

Sustain partnership between the GMP laboratories, the Quality Unit and other laboratory collaborators.

Desired Experience

Required:

BS or MS in science, engineering or related field with 5+ years' experience GMP laboratories or QA function.

Demonstrated ability to influence across departments and sites.

Experienced in authoring and revision of procedures

Experience with periodic review, change management, supporting audits, and quality management system such as TrackWise.

Experience in commercial pharma/biologics manufacturing environment preferred.

Experience with tools for root cause identification and best practices in development of corrective actions.

Ideal Candidate will also have:

Experience with risk assessments associated with data integrity and/or process analytical technology.

Advanced user of with Microsoft applications and experience with Share Point Online.

Six Sigma certification or analytics software experience is a plus.