QA Operations Manager

Position Summary

The QA Operations Manager is responsible for overseeing change control, document control, component review processes, and quality records management. This role ensures compliance with regulatory standards, supports supplier qualification activities, manages product disposition, and maintains audit readiness. The position also provides leadership in monitoring quality system performance, coordinating cross-functional teams, and supporting continuous improvement initiatives.

Key Responsibilities

• Administer and approve site change control processes.

• Maintain production material specifications and records management.
• Support audit readiness and quality compliance for all quality systems.
• Serve as a backup for product disposition, complaint review, and compliance functions.
• Supervise at least one direct report and provide quality metric updates.
• Participate in internal and external audits, corrective/preventive action planning, and follow-up.
• Prepare reports for quality system status and present at review forums.

• Develop, revise, and implement SOPs related to quality systems.

• Support supplier qualification and corrective action processes.

• Manage incoming goods receipt, inventory control, and storeroom audits.

• Oversee cycle counts, purchase requisitions, service orders, and vendor relationships.
• Ensure timely repair and return of equipment and manage consignment inventory.
• Collaborate with maintenance, engineering, and reliability teams on preventive and corrective work.
• Conduct audits of hazardous waste areas and support EHS compliance.
• Lead or participate in lean, six sigma, and continuous improvement projects.
• Perform additional duties as assigned by leadership.

Qualifications

• Bachelors degree in Chemistry, Engineering, or a related scientific field.
• Minimum 3 years of Quality Assurance experience in a GMP-regulated environment (pharmaceuticals or medical devices).
• Experience managing change control systems and raw material release.
• Knowledge of regulations and standards (21 CFR Part 820, ISO 13485).
• Proficiency in quality systems such as TrackWise (or equivalent), document management tools, and SAP (preferred).
• Strong written, verbal, and interpersonal communication skills.

• Knowledge of Lean and Six Sigma principles (certification preferred).

• ASQ auditing certification or equivalent is highly desirable.

• Supervisory or team leadership experience preferred.

• Strong organizational skills, detail orientation, and ability to manage multiple priorities.
• Customer service mindset, able to collaborate across functions and address deviations/complaints constructively.
• Action-oriented with sound judgment, adaptability, and cross-cultural awareness.