Manage the day-to-day activities of the Quality Assurance group consisting of QA operations, quality systems and document management while developing long-term department objectives. Will utilize independent judgment and industry expertise to evaluate and implement systems, methods, techniques, and solutions to complex quality and regulatory compliance issues. Manage and host all regulatory agency and client audits and prepare the responses. Monitors the implementation of any preventative and corrective actions. Have a thorough understanding in ICH guidelines, FDA regulations, GMPs, and Quality Systems relevant to the manufacturing of RSMs and including active pharmaceutical ingredients, and also apply suitable quality system for FC products.
- Recommend and lead implementation of critical compliance systems and provide recommendations to JM Yantai management.
- Contact for regulatory inspections and customer audits, as well as managing any inspections/audits.
- Prepare the site responses to the audit from any requests provided by internal departments and monitor the completion of any corrective actions.
- Recommends the stop of any manufacture and/or distribution of a product if necessary.
- Supervises quality assurance activities including: quality assurance, quality systems, documentation control, and product release.
- Manages the review, approval, and delivery of Quality Assurance related training content and programs including new Quality Assurance initiatives for continuous improvement.
- Independently organizes time, resources, and work activity of the Quality Assurance department based upon on assignments and priorities.
- Direct and advise the Quality Assurance group to achieve long and short term goals and objectives.
- Develop, improve, and revise Standard Operating Procedures (SOPs) and Quality Policies as required/needed.
- Assure the qualification of suppliers and vendor management program.
- Ensure the review and approval of equipment qualification protocols and results.
- Participate in internal auditing programs and management review to assure compliance with regulatory requirements and company standards.
- Other duties as assigned.
Qualifications, Knowledge and Experience
- BS in Chemistry or equivalent with a minimum of 12 years’ experience in Quality Assurance in an FDA regulated industry preferably drug substances
- MS in Chemistry or equivalent with a minimum of 10 years’ experience in Quality Assurance in an FDA regulated industry preferably drug substances.
- Expertise in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of Pharmaceuticals
- Experience supervising and/or managing staff members in a quality department