Associate Director Quality Assurance

GC America; Illinois; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

401(k) through Fidelity and company 10

Dental insurance with Delta Dental PPO

Employee Assistance Program

Health Savings Account

Company Paid Life Insurance two times

Paid time off, including extra week

Job summary

GC America is seeking an Associate Director of Quality Operations & Compliance to lead the site quality organization, ensuring FDA-regulated manufacturing and testing meet cGMP, USP, and ISO standards. The role drives continuous improvement and develops organizational capability for future growth.

You will oversee QA, QC, batch release, CAPAs, deviations, change controls, and validation activities while partnering with Manufacturing, Regulatory Affairs, Validation, and Engineering to uphold

Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Pharma Sciences, Engineering or related field.
• 10+ years of progressive Quality leadership in FDA-regulated environments.
• Direct experience with FDA inspections, 483 responses, and inspection readiness.
• Experience in dental products, pharmaceuticals, OTC or medical devices preferred.

Responsibilities

• Provide quality leadership for QA, QC, and batch release in a regulated setting.
• Direct CAPA, deviations, investigations and change controls.
• Lead site inspection readiness and host FDA/regulatory inspections.
• Develop and monitor quality metrics, dashboards, and process improvements.
• Collaborate with Manufacturing, Regulatory, Validation, and Supply Chain.
• Support supplier quality management and risk-based decision making.

Skills

Quality leadership

FDA/regulatory compliance

Inspection readiness

Cross-functional leadership

Risk management

Education

Bachelor's degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, Engineering, or related field

Advanced degree preferred

Job description

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.

About the Role

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.

Quality Operations Leadership

• 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.

FDA Compliance & Inspection Readiness

• 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.

Quality Control Chemistry & Microbiology Oversight

• 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.

Quality System Management (QMS)

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 ready.

Manufacturing & Technical Operations Support

• Provide Quality oversight for manufacturing operations.
• Support:
• Process and Equipment Validations
• Critical utilities validation
• Review and approve validation protocols, reports, and quality impacting technical documents.
• Partner with Manufacturing to improve process capability, reduce deviations, and improve overall performance.

CAPA, Deviations & Risk Management

• Lead investigations into:
• Deviations, Non-conformances, OOS
• Customer complaints
• Ensure timely implementation of CAPAs
• Apply risk management principles aligned with ISO 14971 to identify and mitigate potential product risks.
• Track effectiveness of corrective actions and ensure closure within defined timelines.

Supplier Quality & Material Controls

• Lead supplier qualification and monitoring programs.
• Ensure compliance with material testing requirements under 21 CFR 211.84.
• Oversee supplier audits and quality agreements.
• Ensure robust controls for:
• Raw materials / Packaging components
• Contract laboratories
• Contract manufacturers
• Bachelor's degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, Engineering, or related scientific discipline required.
• Advanced degree preferred
• 10+ years of progressive Quality leadership experience in FDA-regulated pharmaceutical, OTC, biologics, medical device, or combination product environments.
• Direct experience with FDA inspections, 483 responses, and inspection readiness
• Experience in dental products, pharmaceuticals, OTC products, and/or medical devices preferred.

Technical Expertise

Extensive knowledge of:

• 21 CFR Parts 820, 210 and 211
• ISO13485
• FDA inspection and enforcement processes
• FDA Guidance Documents
• USP requirements and compendial testing
• Proven ability to build and lead high performing Quality organizations.
• Strong executive presence and communication skills.
• Ability to influence across all levels of the organization.
• Strong decision making and risk -based thinking.
• Ability to balance compliance, quality, and business objectives.
• FDA-regulated manufacturing and laboratory setting
• Exposure to dental material compounds requiring PPE and controlled handling procedures
• May involve cleanroom or controlled environments depending on product classification

Why Join GC America

At GC, you will be part of a growing, innovative company with a global footprint. We offer a collaborative, international work environment where your expertise has a direct impact.

BENEFITS:

• 401(k) through Fidelity and company matching 10%
• Dental insurance with Delta Dental PPO
• Employee Assistance Program
• Health Savings Account
• Company Paid Life Insurance two times the annual salary
• Paid time off, including an extra paid week off the week between Christmas and New Year
• Vision insurance EyeMed