Quality Systems Manager
As the Quality Systems Manager, you will play a pivotal role in championing daily activities for quality excellence. You will develop, implement, and enforce quality systems that meet the highest standards, including FDA Drug and Medical Device regulations, customer requirements, and internal business needs.
Here's how you'll make a difference:
- Oversee and streamline deviation/non-conformance investigations and processes.
- Lead the Customer Complaint process, including trending, reporting, and investigations.
- Manage the Product Release Program, batch record review process, metrics, and customer CofAs.
- Spearhead Annual Product Reviews and Quarterly Management Reviews.
- Ensure quality and compliance by supervising the Document Control program, including change control and metrics.
- Develop and maintain quality documents related to job accountabilities.
- Manage the Internal Auditing program, including training, system development, and metrics.
- Partner with QA operations, QA lab, and manufacturing operations to develop and maintain quality systems and processes.
- Represent the company in regulatory inspections, customer audits, and third-party audits.
- Manage Cost of Quality.
- Develop and mentor your direct reports.
Are you the right fit?
- Hold a bachelor's degree in a relevant field (chemistry, microbiology, biology, engineering, etc.) with an advanced degree a plus.
- Possess at least 7 years of experience in FDA-regulated quality assurance systems in manufacturing, including 3+ years in a leadership role.
- Have 5+ years of experience interacting with regulatory bodies (FDA, TGA).
- Be proficient in quality control methods like root cause analysis, risk analysis, and document control.
