Associate Director Quality Assurance

GC America is a global leader in dental care and oral health. With more than 100 years of history, presence in over 100 countries, and a team of over 3,500 people worldwide, we are proud to support dental professionals with innovative, high-quality products that truly make a difference for patients. Our teams across Europe, North America, and Asia work together to develop and manufacture precision components for the dental industry, always focused on quality, innovation, and improving lives.

At GC, we believe in working with care and purpose. Our company philosophy, SEMUI, is all about thinking from the standpoint of others, whether that’s our customers, our teams, or the people who use our products every day. It’s this mindset that helps us drive innovation, respect each other, and create real value for the future of oral health. If you’re looking to join a successful, global company with real career opportunities, we’d love to meet you.

The Associate Director, Quality Operations & Compliance serves as the site Quality leader responsible for building, developing, and sustaining a compliant and inspection ready Quality organization supporting FDA regulated pharmaceutical and medical device manufacturing operations.

This role provides strategic and operational leadership for Quality Assurance, Quality Control (Chemistry & Microbiology), Batch Record Release, and Quality Systems. The position partners closely with Manufacturing, Technical Services, Validation, Engineering, Supply Chain, and Regulatory Affairs to ensure products are manufactured, tested, and released in accordance with applicable FDA regulations, cGMP requirements, USP standards, and company quality objectives.

The position is expected to drive continuous improvement and remediation activities, strengthen quality systems, develop organizational capability, and establish a culture of quality and compliance capable of supporting future growth. This role is viewed as a succession candidate for a future Director of Quality position.

• Direct day-to-day Quality Operations activities supporting manufacturing and laboratory operations.
• Ensure timely review and disposition of:
• Batch records
• CAPAs / Deviations / Investigations
• Change controls
• Validations
• Product impact assessments
• Lead batch disposition and product release decisions in accordance with established quality standards and regulatory requirements.
• Drive quality oversight on the manufacturing floor through active engagement and visible leadership.
• Establish robust metrics and dashboards to monitor product quality, process performance, compliance, and operational effectiveness.

• Ensure compliance with:
• 21 CFR Parts 820, 210 and 211
• FDA Guidance Documents
• USP and compendial requirements
• ISO 13485 and ISO 14971, where applicable
• Maintain a state of continuous inspection readiness across manufacturing, laboratories, warehouses, and quality systems.
• Lead site preparation and hosting activities for:
• FDA inspections
• Regulatory inspections or ISO certification
• Serve as primary Quality representative during regulatory inspections. Also provide updates or correspondence as needed to regulatory bodies.

• Provide strategic oversight of QC Chemistry and Microbiology operations.
• Ensure laboratory systems comply with FDA expectations for:
• Method validation
• Data integrity
• Ensure scientifically sound testing programs for:
• Raw materials / components / finished goods
• Stability programs
• Oversee investigation and resolution of:
• Ensure compliance with applicable USP chapters and compendial requirements.

Provide oversight and continuous improvement for all elements applicable to 21 CFR parts 820, 210, 211:

• CAPA program including investigations and non-conformances
• Design & Change Control
• Complaint Handling including all applicable post-market surveillance activities
• Product Quality Reviews / Annual Product Reviews
• Supplier Quality Management
• Internal Audit
• Training
• Data Integrity
• Documentation Management
• Ensure quality systems are compliant, effective, measurable, and inspection…