This position is accountable for leading strategy and implementation of the client’s Quality Management System and enterprise quality services. Responsibilities include quality functions responsible for Internal and External Audit, Supplier Management, Quality Metrics, Quality Management Review, Change Control, Complaint Handling, GxP Learning and Development and Document Management programs.
- Lead strategy and implementation for the on-going development of Quality Management System encompassing industry best practices and expectations within European, US and worldwide regulations
- Lead and strategically interface with the Quality team responsible for vendor audit and vendor management programs, exclusive of GCP vendors. Progress the internal audit and inspection readiness programs
- Provide leadership and guidance in the development, reporting, and analysis of Quality metrics
- In conjunction with the Quality Head, promote an engaged quality culture across and deliver comprehensive management reviews taking into consideration quality metrics, results of internal audits and external inspections, industry trends and the external regulatory environment
- Provide leadership and guidance in the timely communication/escalation to the Quality Head and Management of issues associated with regulatory compliance/audits findings.
- Stay abreast of changes in European and FDA regulations, directive and guidelines and determine its impact on company studies. Maintain comprehensive knowledge of applicable regulatory requirements and their interpretation
- Develop and lead Change Control Board
- Develop and lead complaint handling processes, trending, analysis, and reporting
- Lead and strategically interface with the Quality team responsible for company-wide GxP learning and development and document management functions
- Participate as a member of the Quality Leadership team fostering a compliant, efficient, effective Quality Management System supporting client’s product development and commercial objectives
- Represent QMS in health authority inspections and internal audits
- Build and lead a team of engaged quality professionals.
- Other duties as assigned
- Travel ~10-20% as requested
- Bachelor’s degree in a scientific discipline, with an advanced degree, preferred
- 10+ years of experience in the pharmaceutical industry; with 5+ years of experience directing multiple Quality Management functions and staff including such area as; QMS leadership, vendor management, document management, learning & development and recruiting, managing and developing high-performance team
- Extensive experience implementing, interpreting, and providing guidance on applicable domestic and international regulations.
- Experience with GMP/GCP/ICH standards and regulatory guidance documents
- Strong cross-functional collaboration skills with emphasis on Project Management and Process Excellence
- Experience managing electronic Quality Management Systems is required. Experience with computer system validation strongly desired
Competencies and Attributes:
- Demonstrated leadership ability to drive results that are needed to achieve the company objectives in accord with the client’s core cultural values of courageous, creative, selfless and humor
- Well-organized and detailed oriented professional, with strong verbal and written communication skills
- Demonstrated ability to effectively collaborate and partner with functional management while maintaining an appropriate assertive style
- Good computer skills with experience and working knowledge of MS Office (Word and Excel, Access, Adobe Acrobat professional)