The Associate Director of Quality is responsible for developing, implementing and maintaining site compliance strategies and quality systems. The Associate Director is responsible for staying current with proposed and implemented regulations and understanding industry trends. This position interfaces and collaborates with corporate and other site management in assuring that the site is fully compliant with relevant regulatory standards. The Associate Director is responsible for transitioning developmental products into Quality Systems and overseeing compliance. The Associate Director is a key participant in site regulatory agency inspections. The position manages a team of QC Technicians, Manager, Quality Control, Manager, Quality Engineering and Quality Systems Analyst.
- Provide strategic and tactical direction for Quality Systems design and maintenance.
- Manage key site quality systems such as Change Control, NCMR’s, CAPAs, Internal Auditing, Document Management and Control, Labelling artwork approval, Technical Agreements etc, Measure and report site performance on key indictors of these quality systems through metrics.
- Ensure quality system performance is appropriately and well communicated throughout site
- Provide guidance and assessments on other site Quality Systems.
- Ensure site applicable aspects of regulatory submissions are appropriately reviewed for consistency between site procedures and methods and regulatory submissions
- Ensure site compliance with relevant Medical Device regulations
- Develop and sustain a culture of constant site readiness for site inspections
- Implementation of strategies to keep the site ahead of the compliance curve
- Develop a support/service mentality in Quality staff
- Serve as a key participant in site regulatory agency inspections
- Support daily activities, ensuring Quality personnel execute their work in strict accordance with SOPs, and cGMP guidelines
- Seek process innovation and continuous process improvement in Quality function.
- Allocate and coordinate personnel resources to all Quality compliance activities and provide direction to ensure that specified targets for the team are met.
- Maintain accountability for own team’s performance metrics
- Contribute to the continual improvement of Quality documentation and ensure that they are current, accurate and clearly define process and role responsibilities
- Provide hands on training, support and coaching and ensure that performance targets can be met.
- Complete and conform to all training requirements for job role, including company required and job role specific training
- Bachelor’s degree in biological science or engineering (mechanical, industrial, chemical, electrical) is preferred
- Minimum of 5 years of experience managing Quality in an FDA/ISO regulated Manufacturing Environment