QA Manager - Analytical Laboratory Support
Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: October 11, 2019
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.Summary:--- Provide Quality
oversight for testing of clinical supplies (investigational
products) to assure quality and compliance with Good Manufacturing
Practices (GMP) and other applicable regulations and internal
procedures.--- Coordinates the assignment of tasks to be performed
by the assigned managers/Associates/Specialists.--- Assure the
quality of manufactured products complies with all applicable
regulations and guidelines.Responsibilities:
- Conducts, plans, schedules, or supervises the review and
approval of laboratory data, and other documentation as
- Reviews and approves documents related to Quality Systems such
as laboratory investigation reports (OOA, OOS), test method
validation protocols or reports, test specifications, SOPs/WIs,
change controls, raw material release, etc.
- Drafts and/or reviews Quality Agreements, as requested.
- Supports site operations during regulatory agency and third
- Provides on-the-job training to Quality Operations personnel
and GMP training to functional areas, as appropriate.
- Brings to the attention of the Quality Operations Management,
any information relating to the impact of legislation on the
functions of the department, system deviations, etc.
- Provides reports to Management related to timely CAPA
implementation, as requested.
- Provides support to PD/DPST-Device Operations for overall
quality system and review of protocols and procedures, as
- Build and foster strong relationships and partnerships with
stakeholders and support groups to meet the demands of a changing
business culture and environment.
- Provides instruction and guidance on quality issues and serves
as a resource for the site.
- Adherence to BMS core behaviorsProfessional experience and
- Knowledge of science generally attained through studies
resulting in B.S. or M.S. in chemistry, pharmacy or biology or a
related pharmaceutical science
- A Ph.D. in a related science with 4-6 years of relevant
experience within the pharmaceutical or healthcare industry, or a
M.S. with 7-9 years experience, or a B.S. with 9-11 years
experience; including 3-5+ years experience in a regulated
- Knowledge of biopharmaceutical analytical methods
- Experience within a QA/QC environment is required
- Technical expertise in resolution of deviations and development
of effective CAPA
- Experience in Quality Management at development and/or
commercial stage of pharmaceutical operations
- Broad experience in the manufacturing of sterile and
- In-depth knowledge of GMP regulations
- Strong problem solving, interpersonal and organizational
- Strong collaborative and influencing skills
- Effective written and verbal communication
- Computer literacy: Microsoft Office and SAP environment
Trackwise--, PDLIMs, and other systems as requiredBristol-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.
Keywords: Bristol-Myers Squibb Company, New Brunswick , QA Manager - Analytical Laboratory Support, Executive , New Brunswick, New Jersey
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