Manager, QA Operations

About the Role

The Manager, QA Operations is responsible for leading QA Operations activities that support manufacturing, packaging, and release processes while ensuring compliance with applicable regulatory requirements, company procedures, and quality standards. This position manages a team of QA professionals and provides quality oversight of manufacturing operations, investigations, batch record review, and product disposition activities at our Manufacturing Facility in Fort Worth, TX.

Quality Oversight

• Provide quality oversight and support for manufacturing, packaging, and warehouse operations
• Ensure compliance with FDA, EU GMP, ISO, and other applicable regulatory requirements
• Act as the primary QA representative for operational quality issues
• Support review and approval of manufacturing and packaging documentation
• Partner with site leadership to drive a culture of quality and compliance

Quality Systems Management

• Oversee investigations, deviations, nonconformances, CAPAs, and change controls
• Ensure timely and effective closure of quality records in accordance with established procedures
• Monitor quality system performance metrics and identify improvement opportunities
• Support internal, customer, and regulatory audits and inspections

Product Release and Disposition

• Ensure timely review and disposition of product batches
• Oversee batch record review processes and disposition decision-making
• Assess potential product quality risks and determine appropriate actions when quality concerns arise
• Support product impact assessments related to deviations, complaints, and investigations

Qualifications

• Bachelor's degree or equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+1 yr)
• The ability to fluently read, write, understand and communicate in English
• 5 years of relevant experience
• 3 Years of demonstrated leadership

Preferred Knowledge and Skills

• Strong understanding of FDA regulations, GMP requirements, ISO standards, and quality systems
• Knowledge of risk management principles and quality decision-making processes
• Strong investigation and root cause analysis skills
• Excellent verbal and written communication skills
• Ability to influence cross-functional teams and drive compliance-focused decisions
• Strong analytical and problem-solving abilities
• Experience utilizing quality systems and electronic documentation platforms

Key Competencies

• Leadership and Team Development
• Quality Systems Expertise
• Regulatory Compliance
• Risk-Based Decision Making
• Operational Excellence
• Investigation and Root Cause Analysis
• Strategic Thinking
• Cross-Functional Collaboration
• Change Leadership
• Results Orientation

Schedule

Monday – Friday, 8:00 AM – 5:00 PM CST. Onsite. Travel up to 10%.