Senior Lead - Quality Assurance/Quality Control – Metrology

Burkert USA Corp; Charlotte (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Tuition assistance

Job summary

A leading manufacturing company in Charlotte, NC seeks a Senior Leader QA/QC to oversee quality assurance and control functions. The ideal candidate will have over 10 years of experience in regulated industries and will lead compliance with FDA and ISO standards. Key responsibilities include managing QA/QC teams and driving continuous improvement initiatives. A Bachelor's or Master's degree in a relevant field is required, along with strong leadership skills. This role offers a comprehensive benefits package.

Qualifications

• 10+ years of experience in QA/QC roles in Biopharma or related industry.
• 5+ years in a leadership role.
• Strong knowledge of FDA and ISO standards.

Responsibilities

• Lead and manage QA/QC departments.
• Develop and maintain quality management systems.
• Ensure compliance with regulatory requirements.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Microbiological Testing

Statistical Analysis

Continuous Improvement

Education

Bachelor's or Master's degree in relevant field

Tools

SAP

Digital QMS platforms

Job description

Overview

The Senior Leader QA/QC is responsible for directing and overseeing the quality assurance and quality control functions across the organization to ensure compliance with applicable regulatory requirements (e.g. FDA, cGMP, ISO 9001). This role ensures that all products meet the highest quality standards before they reach the market and drives a culture of continuous improvement in quality systems and manufacturing operations.

Responsibilities

• Lead and manage QA/QC departments, including Quality Systems, Quality Control Laboratories, Document Control, and Compliance.
• Develop, implement, and maintain robust quality management systems in alignment with regulatory standards (cGMP, ISO 9001, FDA, cGMP).
• Ensure compliance with all relevant regulatory requirements and serve as the point of contact for audits and inspections (e.g., FDA, USDA, ISO certifying bodies).
• Drive continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction.
• Oversee product release, change control, CAPA (Corrective and Preventive Actions), and deviation management.
• Lead internal audits and supplier qualification programs; manage external audit readiness and responses.
• Collaborate with cross-functional departments including R&D, Manufacturing, Supply Chain, and Regulatory Affairs to ensure quality objectives are integrated throughout the product lifecycle.
• Hire, train, and mentor QA/QC personnel; build high-performing teams.
• Monitor key quality metrics and report to executive leadership.
• Stay current on industry trends, emerging regulations, and best practices.
• Support Change Management Team
• Drive/Support Sustainability within QA/QC
• Participate in Safety Council with cross-functional team
• Develop Lab and Metrology methodology
• Collaborate with Manufacturing/Assembly and align on continuous improvement of manufacturing processes (welding, machining, assembly, injection molding)

Qualifications

• Bachelor's or Master's degree in Life Sciences, Food Science, Chemistry, Engineering, or a related field.
• 10+ years of progressive experience in QA/QC roles in Biopharma, Food & Beverage, or related regulated industry.
• 5+ years in a leadership role
• Strong knowledge of regulatory requirements (FDA, cGMP, ISO standards).
• Experience with laboratory operations, microbiological and chemical testing, and analytical method validation.
• Demonstrated success in leading regulatory inspections and audits.
• Demonstrated expertise within Metrology (CMM programming, Statistical Analysis)
• Excellent leadership, communication, and organizational skills.
• Lean Six Sigma or other continuous improvement certification is a plus.
• Prior experience in both Biopharmaceutical and Food & Beverage industries.
• Knowledge of digital QMS platforms
• SAP literacy
• Ability to manage QA/QC function and drive global initiatives.

Burkert Culture

Burkert USA Corp is a manufacturing and sales organization, that is family owned and was established in the US in 1984. Burkert employees enjoy an inclusive environment that's open to ideas and innovation for a growing company with opportunities for development. Work life balance is considered a priority with a comprehensive benefits package in place to support your personal and professional life.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Quality Assurance, Engineering, and Manufacturing

Industries

• Automation Machinery Manufacturing
• Food and Beverage Manufacturing
• Industrial Machinery Manufacturing

Benefits

• Medical insurance
• Vision insurance
• 401(k)
• Tuition assistance