Position Summary: As a Quality Systems Manager, you will play a pivotal role in our FDA regulated manufacturing facility. Your primary responsibility will be implementing and overseeing daily activities for quality systems. You will develop, implement, and maintain quality systems that adhere to FDA Drug and Medical Device regulations, customer requirements, and internal business needs.

Position Responsibilities:

• Manage and support deviation/non-conformance investigations and processes.
• Oversee the Customer Complaint process, including trending, reporting, and investigations.
• Manage the Product Release Program, batch record review process, metrics, and customer CofAs.
• Lead Annual Product Reviews and Quarterly Management Reviews.
• Supervise the Document Control program, including change control and metrics.
• Create and revise quality documents related to job accountabilities.
• Manage the Internal Auditing program, including training, system development, and metrics.
• Collaborate closely with QA operations, QA lab, and manufacturing operations to develop and maintain quality systems and processes ensuring regulatory compliance.
• Act as a key participant in regulatory inspections, Customer, and 3rd party audits. Manage Cost of Quality.
• Develop and mentor direct reports.

Position Requirements:

• A Bachelor's degree in chemistry, microbiology, biology, engineering, or related science discipline. Advanced degree preferred.
• Minimum seven years' experience in pharmaceutical, medical device, or other FDA-regulated quality assurance systems in manufacturing, with at least three years in a leadership or advisory role.
• Five or more years of experience interacting with a regulatory body (e.g., FDA, TGA).
• Proficiency in root cause analysis, risk analysis methods, leading investigations, managing audits, regulated document systems, change management, complaint management, and non-conformance/deviation management.