Senior Lead - Quality Assurance/Quality Control - Metrology

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 #J-18808-Ljbffr Burkert USA Corp