Quality Manager

The Quality Manager is responsible for developing, implementing, and maintaining quality systems in an FDA‑regulated manufacturing environment. This role ensures compliance with FDA Drug and Medical Device regulations, customer requirements, and internal business standards. The individual will oversee daily quality systems operations, lead key compliance processes, and partner closely with cross‑functional teams to drive continuous improvement.

Responsibilities

• Lead and manage deviation and non‑conformance investigations, including CAPA development and execution.
• Oversee the Change Management process to ensure controlled, compliant updates to regulated systems and documentation.
• Manage the Customer Complaint process, including investigation, trending, reporting, and corrective actions.
• Oversee the Product Release Program, including batch record review, metrics, and customer Certificates of Analysis (CoAs).
• Direct the Annual Product Review and Quarterly Management Review processes.
• Manage the Document Control program, including controlled document changes, approval workflows, and performance metrics.
• Lead the Internal Auditing program, including auditor training, system development, and performance metrics.
• Collaborate with QA Operations, QA Laboratory, and Manufacturing to maintain compliant quality systems throughout the facility.
• Serve as a key participant during regulatory inspections, customer audits, and third‑party audits.
• Manage the facility's GMP and sanitation programs and related improvement initiatives.
• Provide leadership, coaching, and development for direct reports.
• Demonstrate and promote Rockline/Iatric's RRITE values: Renew, Respect, Integrity, Teamwork, and Excellence.
• Uphold and model safety standards; this role is classified as Safety‑Sensitive.
• Perform additional duties as assigned to support business needs.

Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Engineering, or related scientific discipline required.
• Advanced degree preferred.
• Minimum of 7 years of experience in pharmaceutical, medical device, or other FDA‑regulated manufacturing quality systems.
• At least 3 years in a leadership or advisory capacity.
• 5+ years of experience interacting with regulatory agencies (e.g., FDA, TGA).
• Demonstrated experience in root cause analysis, risk assessment, investigations, audits, document control, change management, complaint handling, and deviation management.