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
1. Develop, implement and manage the Company's Quality Assurance function, meeting all F.D.A. regulatory, compliance and cGMP requirements. Responsible for assuring those overall quality standards are maintained throughout raw material testing, batch manufacturing, filling, finished product testing, and the control and release of products for distribution to our clients.
2. Apply leadership skills to actively support the Company's objectives by conducting all work in a professional, ethical and confidential manner.
3. Work closely with R & D in developing and evaluating product specifications.
4. Coordinate all testing with sub-contracted laboratories, review and approve results.
5. Manage out of specification situations by analyzing for root cause and implementing necessary
6. Insure the Quality staff is properly trained in all appropriate Standard Operating Procedures and cGMPs.
7. Manage Quality Assurance Key Performance Indicators and develop plans for improvement.
8. Develop and implement protocols for cleaning and process validation for all OTC products.
9. Be responsible for ensuring that the overall business unit processes and initiatives are compliant with all applicable external standards and regulatory requirements. Ensure that regulatory strategies adequately support product development activities and result in the timely global approval of new and revised products.
10. Responsible for the development, implementation, maintenance and improvement of the quality system. Ensure that the quality systems functions such as complaint handling, corrective and preventive action, and the internal audit program are effective and compliant.
11. Monitor external changes to the regulatory environment to ensure the continued compliance of the quality system.
12. Conduct appropriate quality planning to support organizational change and growth.
13. Provide direction, feedback, and mentoring to direct reports to ensure that staff development is occurring.
14. Define with the staff goals for personal and professional development
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.