Manager, Quality Assurance
Manager, Quality Assurance
The Manager of Quality Assurance position is responsible for oversite of the Quality Management System (QMS). This position provides support and guidance to ensure compliance with regulatory requirements as well as maintain and update information to those requirements.
- Implements and oversees the QMS for the company.
- Educates and trains employees as to their impact in the QMS.
- Interacts with Suppliers to identify opportunities to improve quality and monitor performance.
- Interfaces with Supplier quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
- Reviews and trends quality issues.
- Implements quality improvement activities as appropriate to raise the performance of the company.
- Implements metrics (process capability, control charts, measurement of quality) for monitoring system effectiveness and enable managers to make sound product quality decisions.
- Participates in internal and external quality audits.
- Possesses working knowledge of International Standards, and cGMPs.
- Reports to the Associate Director, Quality.
- Works frequently in cross functional teams including Regulatory, Product Development, and CMC Operations to create positive outcomes.
Candidate Requirements (External)
- Required Competencies:
- Organizational Skills
- Communication Proficiency
- Problem Solving and Analysis
- Technical Capacity
- Time Management
- Required Education and Experience:
- Bachelor’s degree in science, engineering or business discipline or equivalent number of years of experience.
- 5 years of experience in QA systems implementation and management.
- Experience hosting and conducting audits.
- Preferred Education and experience:
- Master’s degree in science, engineering or business discipline field or equivalent number of years of experience.
- Six Sigma certification and a track record of business performance improvement.
- Experience hosting FDA and other regulatory authority audits.
- Travel Expectations:
- Out of the area overnight and international travel may be expected.
- Physical Demands:
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
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