The Director of Quality Assurance and Regulatory is responsible for the oversight and leadership for developing, implementing, and maintaining of all quality management systems across Aldevron's operating divisions. Along with the alignment of their associated interdependencies to assure compliance to domestic and international standards and regulations for cGMP. This position will engage in cross-functional and cross-company matrixed teams and also interfaces with all other areas within Aldevron.
Essential Functions and Skills:
- Maintain a risk-based and scientific-based quality system
- Ensure that GMP service platforms will carry out tactical day-to-day regulatory functions.
- Monitor the regulatory environment globally and provide expertise and guidance in interpreting government regulations, agency guidelines, and internal policies to provide assessments of the impact of new and changing regulations.
- Provide technical and organizational leadership and direction to quality and regulatory programs and activities.
- Ensure all GMP operations are in compliance.