QA MANAGER

Job Responsibilities:

In collaboration with Clinical Supply Operations, and other Pharmaceutical
Development functions, ensure compliance with global cGMP regulations and
company procedures for the production of investigational medicinal products.
Schedules andperforms review of drug product manufacturing batch records,
packaging amp labeling records, and other associated documentation, and approve
products for clinical use. Participates in a team environment to investigations
into quality incidents associated with production of investigational products.
Tracks and trends deviationincident investigations and associated corrective
and preventive actions. Develops and reviews SOPs, other procedural documents
as needed, and develops and delivers GMP training to internal customers as
required. Provides guidance on CGMP issues, interpretation of the regulations
and maintains awareness of industry trends.

Job Requirements/Education:

A Ph.D. in Chemistry, Pharmacy, or related discipline with 4 to 6 years of
relevant experience within the pharmaceutical or healthcare industry, or a M.S.
with7 to 9 years of experience, or a B.S. with 9 to 11 years of experience
including 2 to 4 years experience in a regulated function. Requires knowledge
and understanding of cGMP regulations as they pertain to clinical supplies
production activities. Knowledge of the pharmaceutical development continuum is
important. Experience in a QA organization or in a clinical production
environment is a plus. Strong computer skills and the ability to learn new
software applications Trackwise, SAP, DeltaV, LIMS are critical. Excellent
judgment, strong organizational and communication skills and an ability to
handle multiple tasks are key attributes of a successful candidate. The ability
to interact constructively in a team approach to problem solving is important.

Salary will be commensurate with experience.
Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D