Apply to Quality Assurance Regional Manager

Location: Defiance, OH or Bridgeton, MO
Industry: Food, Dietary Supplements, Pharmaceutical, Medical Device, or Related Manufacturing
Position Type: Full-Time
Travel: Regional travel between manufacturing sites as required
 Base Salary - USD $130,000 to $145,000
 

Seeking a experienced Regional Quality Assurance Manager to provide quality leadership across multiple manufacturing sites in the Midwest. This is a key leadership position responsible for ensuring products are safe, compliant, and consistently meet customer and regulatory requirements.

The Regional Quality Assurance Manager will lead and develop regional quality teams while partnering closely with Operations, Production, R&D, Engineering, Commercial, and other cross-functional teams. This individual will drive continuous improvement, strengthen quality systems, reduce risk, and promote a culture of quality excellence across the organization.

The ideal candidate will have 10+ years of Quality Assurance experience in an FDA-regulated manufacturing environment, with strong knowledge of FDA regulations, HACCP, SQF, food safety, and quality management systems.

Key Responsibilities

Quality Leadership & Team Development

• Lead, develop, coach, and mentor Quality Assurance teams across multiple manufacturing sites.
• Establish and communicate quality goals and expectations throughout the region.
• Build strong relationships with Operations, Production, R&D, Engineering, Commercial, and other business functions.
• Promote a culture of accountability, continuous improvement, and quality excellence.
• Develop and deliver training programs related to food safety, quality, and regulatory compliance.
• Establish clear goals using tools such as SMART objectives and standardized work processes.
• Ensure timely escalation and communication of quality, food safety, regulatory, and financial issues.
• Communicate effectively with internal and external customers.

Quality Systems & Compliance

• Provide regional leadership for Product Safety, Product Quality, and prerequisite programs.
• Ensure quality systems are effectively integrated with change control, commercialization, and new product introduction processes.
• Maintain and continuously improve internal audit programs.
• Ensure corrective and preventive actions are completed effectively and on schedule.
• Monitor quality systems to identify and reduce operational and regulatory risks.
• Ensure professional, timely responses to customers, inspectors, and external auditors.
• Support customer visits, regulatory inspections, and external audits.
• Share best practices and promote consistency of quality systems across multiple sites.

Continuous Improvement & Root Cause Analysis

• Lead root cause investigations and implement sustainable corrective actions.
• Utilize basic root cause analysis and problem-solving tools to prevent recurrence.
• Identify opportunities for process, engineering, and system improvements.
• Drive improvement initiatives based on key quality and operational performance indicators.
• Monitor metrics including:
  • Inspection and compliance performance
  • First Pass Quality
  • Customer complaints
  • Product disposal
  • Inventory health
  • Customer responsiveness
  • CAPA closure and effectiveness
  • Quality system performance
  • Environmental and sanitation performance
• Partner with Operational Excellence teams to maximize continuous improvement initiatives.

New Product & Process Introduction

• Collaborate with R&D, Production, Engineering, and Commercial teams on new products, processes, and equipment.
• Support successful new product and customer launches.
• Identify potential risks and develop appropriate mitigation strategies.
• Evaluate first-time production runs and communicate risks, opportunities, and recommendations.
• Ensure quality and food safety requirements are incorporated into commercialization and production processes.

Required Qualifications

• Bachelor's degree in Science, Food Science, Chemistry, Biology, Engineering, or a related field.
• 10+ years of Quality Assurance experience, including significant management or leadership experience.
• Experience working in an FDA-regulated manufacturing environment.
• Experience in one or more of the following industries:
  • Food & Beverage Manufacturing
  • Dietary Supplements
  • Pharmaceutical Manufacturing
  • Medical Device Manufacturing
  • Related regulated manufacturing
• Strong knowledge of FDA regulations, HACCP, SQF, food safety, and quality best practices.
• Demonstrated experience leading and developing Quality teams.
• Strong knowledge of quality systems, internal auditing, CAPA, root cause analysis, and continuous improvement.
• Experience with Statistical Process Control (SPC) and process improvement.
• Strong project management, organizational, and prioritization skills.
• Excellent communication and interpersonal skills with the ability to influence cross-functional teams.
• Must be a U.S. Citizen or Permanent Resident.

Preferred Qualifications

• Experience managing Quality Assurance across multiple manufacturing sites.
• Experience with food safety and sanitation programs.
• Experience preparing for and participating in FDA, customer, SQF, or other external audits.
• Experience implementing or improving quality management systems.
• Strong mentoring and supervisory experience.
• Experience working within Operational Excellence or Continuous Improvement programs.