Quality Assurance Lead

Overview:

Business Title: Quality Assurance Lead

Position Title: Quality Assurance Specialist V

Division: Consumer Products Services

Entity: Galbraith Laboratories

Reports to: Sr Manager, QHSSE  

FLSA: Exempt

 

Location: Knoxville, TN

 

Hours Worked: Typically, Monday through Friday, 40 per week

However, must be flexible to meet the needs of the department and complete other projects as assigned.

Major Roles & Responsibilities

External Representation & Regulatory Affairs

• Lead customer audits independently, and support QA Manager for regulatory inspections & agency visits
• Draft audit responses and corrective action plans
• Monitor regulation changes, assess risk, and close compliance gaps
• Assist with facilitating scope expansion with regulating/certifying bodies

Strategic Management

• Participate in cross-departmental corrective activities based on trends
• Support quality event trending and corrective actions
• Facilitate cross-departmental communication
• Improve efficiency and effectiveness of quality processes

Reporting & Oversight

• Assist in preparing Management Review Meeting reports
• Report quality systems status to QA Manager
• Develop tracking/trending tools and communicate trends to leadership
• Collaborate with managers on company policies, goals, and procedures

Advanced Technical Authority

• Oversee CAPA system
• Ensure departmental priorities, goals, and policies are met
• Oversee Quality Assurance Unit policies/procedures
• Approve/reject procedures and specifications for data/client reports
• Review and approve investigations, deviations, and change controls
• Direct inspections and audits for materials, facilities, and test results
• Advise Quality Manager on regulatory strategy and developments

Client Relations

• Resolve client issues to enhance satisfaction
• Lead client audits
• Track deviations, change controls, and complaints

Knowledge, Skills & Abilities

Core Competencies

• Leadership: Lead, develop, and motivate QA teams
• Communication: Exceptional written/verbal skills for executive reporting and stakeholder engagement
• Regulatory Expertise: Deep understanding of requirements and proactive compliance management
• Technical Proficiency: Advanced knowledge of QMS, statistical analysis, and validation

Technical Skills

• Expertise in QMS implementation and continuous improvement
• Thorough understanding of ISO 9001, 17025, CFR 210, 211, 820
• Proficient in quality data analysis, trending, and reporting
• Advanced proficiency with QMS software, databases, and statistical tools
• Expert knowledge of GLP, GMP, and regulatory frameworks

Management & Leadership

• Train and develop QA team on data analysis and quality management
• Strong interpersonal and relationship-building skills
• Oversee large, cross-departmental projects
• Excellent project management and coordination skills

Analytical & Problem-Solving

• Advanced problem-solving for complex quality challenges
• Manage multiple high-priority projects simultaneously
• Expertise in root cause analysis and corrective action implementation
• Strong attention to detail with strategic perspective

Additional Competencies

• Organizational and time management excellence
• Proactively interpret and apply new regulations
• Positive attitude, self-motivated, highly engaged
• Proficiency with Windows, Word, Excel, and specialized quality software

Experience & Educational Background

Required Qualifications:

• Bachelor's Degree + 7 years QA experience with progressive responsibility

OR

• Master's Degree + 5 years QA experience with progressive responsibility

Preferred:

• Laboratory/manufacturing quality management experience
• Regulatory inspection representation experience
• Multiple QMS experience (ISO 17025, ISO 9001,