Strategic Contract Compliance & Quality Leader

Baxters North America; Cincinnati (OH); On-site; USD 110,000 - 140,000; Full time

Job summary

Baxters North America is seeking a Contract Compliance & Quality Manager to lead quality and regulatory efforts across military, government, and strategic accounts. You will interpret complex requirements, drive audits, corrective actions, and continuous improvement initiatives to ensure product and process compliance.

The role partners with Operations, Engineering, and Supply Chain to implement and maintain compliant practices, while guiding cross-functional teams and mentoring staff for growth

Qualifications

• Bachelor's degree in a related field or equivalent experience in a regulated industry.
• 5+ years in quality, compliance, regulatory affairs, or contract administration in a regulated setting.
• Experience auditing, managing corrective actions, and leading cross-functional teams.

Responsibilities

• Serve as the primary quality representative for military, government, and strategic accounts.
• Interpret customer specifications and regulations to ensure compliance across the organization.
• Develop, review, and administer waivers, deviations, and concessions with customers.
• Lead customer communications on quality concerns, investigations, and corrective actions.
• Establish and maintain quality management systems aligned with requirements.
• Lead audits and assessments by customers, government bodies, and third parties.
• Manage corrective actions from audits, complaints, and findings.
• Collaborate with Operations, Engineering, Supply Chain, and Programs departments to implement requirements.
• Conduct risk assessments and facilitate root-cause investigations to mitigate risks.
• Monitor changes to requirements and implement process improvements accordingly.
• Develop KPIs for compliance, quality, and customer satisfaction.
• Manage customer complaints, nonconformances, and verification activities.
• Build relationships with customer representatives and regulatory authorities.

Skills

Customer Requirements Management

Customer Relationship Management

Contract Compliance

Regulatory Compliance

Regulatory Reporting

Quality Assurance

Reliability Analysis

Audit Management

Risk Assessment

Root Cause Analysis

Leadership

Problem-Solving

Project Management

Decision-Making

Strong Communication Skills

Stakeholder Influence

Continuous Improvement

Operational Excellence

Education

Bachelor's degree in Quality Management / Engineering / Regulatory Affairs

Tools

Quality Management Systems (QMS)

Job description

Baxters North America is seeking a Contract Compliance & Quality Manager to lead quality and regulatory efforts across military, government, and strategic accounts. You will interpret complex requirements, drive audits, corrective actions, and continuous improvement initiatives to ensure product and process compliance.

The role partners with Operations, Engineering, and Supply Chain to implement and maintain compliant practices, while guiding cross-functional teams and mentoring staff for growth