Quality Assurance Lead

Location:

Knoxville, Tennessee, US

Type of contract: Permanent

Posting date: Aug 29, 2026

Job offer reference: 208245

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

Required Qualifications:

Experience & Educational Background

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

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, GLP, GMP)

Compensation Range: $75,000 - $90,000 annually (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset)

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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

Required Qualifications:

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

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, GLP, GMP)

Compensation Range: $75,000 - $90,000 annually (e.g., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset)

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

Required Qualifications:

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

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, GLP, GMP)

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