MANAGER, REGULATORY QUALITY COMPLIANCE

Job Responsibilities:

1.Lead organization and execution of Regulatory Quality Compliance initiatives.
Serve as key liaison between Manufacturing and support groups e.g. Quality
andCompliance, Manufacturing Technology, Supply Chain, Regulatory Sciences
across the BMS network. 2.Assure uniformity in program execution across all
sites in accordance with site, divisional, and corporate policies. 3.Provide
technical expertise, training, and assistance to manufacturing sites for
preparation of Chemistry, Manufacturing, and Control sections of regulatory
applications. 4.Assure project performance objectives are met according to
established schedules and budget. 5.Establish objectives and delegate
assignments for project execution. 6.Communicate routinely with assessment
teams, QampC management, Regulatory, and site functions to manage project
execution and provide project status updates. 7.Incorporate technical and
compliance expertise and judgment to all aspects of Regulatory Quality
Compliance initiatives, including categorization and justification of impact
severity. 8.Evaluate, plan, track and coordinate project remediation actions to
assure successful and timely execution, in accordance with detailed time and
event schedules. 9.Supervise and manage performance of contract staff.
10.Develop and implement quality systems and related policies, guidelines, and
procedures to support regulatory compliance. Responsible to assure coordination
with other areas of the organization. 11.Appraise project issues with regard to
regulatory requirements. 12.Incorporate project management, statistical tools,
and other techniques to perform assessments and coordinate projects.

Job Requirements/Education:

Education B.S. or advanced degree in Pharmaceutical Sciences or Chemical
Engineering. 2.Expertise in pharmaceutical manufacturing process or analytical
technology. Breadth of technical knowledge is demonstrated by ability to ask
innovative and probing questions when presented with unique or difficult
issues. 3.Familiarity with the global manufacturing networks, and direct
experience with multiple facilities and personnel. International experience
desired. 4.Direct experience with multiple functional areas and many levels
throughout the an operations organization. 5.Demonstrated knowledge of formal
and informal operations systems and databases, including cultural and
historical background and experience. 6.Demonstrated ability to lead through
ambiguity. 7.Demonstrated project management ability including experience
concurrently managing major projects. 8.Knowledge of regulatory CMC content and
filings, FDA regulations, EU regulations and cGMPs. 9.Computer literacy
Microsoft applications. 10.Technical writing, oral communication, and
presentation skills. 11.Demonstrated analytical and problemsolving skills.
12.Demonstrated leadership skills, time management, and planning and
organization capabilities. 13.The individual should be a self starter.

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