East Haven, CT | Perm
Quality Assurance Manager
This position is responsible for leadership of Quality Assurance and Regulatory Affairs functions and for the promotion of quality awareness and continuous improvement throughout the organization. The position will report to the Vice President of Operational Excellence and Quality Assurance
The successful candidate will have extensive knowledge and experience in quality systems, quality improvement, quality measurement standards and regulatory affairs activities within the cosmetic, pharmaceutical or food industries.
" Minimum of 5 years of experience managing and developing others.
" BS degree in Engineering, Science or a related field or equivalent required. Master's degree a plus.
" Strong project management experience is also required.
" Strong knowledge of statistical process control, IQ/OQ/PQ, calibration, risk management and health hazard evaluations, Process Validation, CAPA, supplier quality, and distribution processes.
" Subject matter expert on New Product Commercialization, FDA's design control requirements and Risk Management. Knowledge of Six Sigma tools (including Design for Six Sigma).
" Must have proven track record of ability to influence and direct others that do not report directly to him/her.
" Successful participation in the implementation of a quality system compliant with FDA and international quality standards.
" Previous interaction with the U. S. Food and Drug Administration
" Appropriate quality-related and/or regulatory certifications highly desired.
" Must have hands on experience dealing with FDA Inspections.