Laboratory Compliance Manager
- Employer
- Bristol Myers Squibb Company
- Location
- New Brunswick, NJ, United States
- Start date
- Apr 23, 2019
View more
- Discipline
- Regulatory, Legal/Compliance, Science/R&D, Laboratory
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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.
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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