QUALITY ASSURANCE LEAD

About the role

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: Typically Monday–Friday, 40 hours per week; must be flexible to meet department needs and complete other assigned projects.

Responsibilities

• External Representation & Regulatory Affairs
  • Lead customer audits independently and support the QA Manager for regulatory inspections and 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 the QA Manager.
  • Develop tracking/trending tools and communicate trends to leadership.
  • Collaborate with managers on company policies, goals, and procedures.
• Advanced Technical Authority
  • Oversee the CAPA system.
  • Ensure departmental priorities, goals, and policies are met.
  • Oversee Quality Assurance Unit policies and procedures; approve or 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 the Quality Manager on regulatory strategy and developments.
• Client Relations
  • Resolve client issues to enhance satisfaction.
  • Lead client audits.
  • Track deviations, change controls, and complaints.

Requirements

• Experience & Educational Background
  • Bachelor’s Degree plus 7 years of QA experience with progressive responsibility, or
  • Master’s Degree plus 5 years of QA experience with progressive responsibility.

Preferred Qualifications

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

Skills

• Core Competencies
  • Leadership: Lead, develop, and motivate QA teams.
  • Communication: Exceptional written and 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, ISO 17025, 21 CFR 210, 211, and 21 CFR 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.

Pay

Compensation range: $75,000 – $90,000 annually (actual compensation may vary by location, education, experience, and skillset).