Manager, Quality and Compliance

EPM Scientific; Madison (WI); On-site; USD 110,000 - 170,000; Full time

Job summary

EPM Scientific in Madison, WI, seeks a Quality & Compliance Manager to oversee quality systems, compliance initiatives, and regulatory activities in a GMP-regulated pharmaceutical/biotech environment. This leadership role partners with internal stakeholders to drive quality across the organization and support inspection readiness.

You will lead quality personnel, manage audits and supplier quality programs, CAPAs, change control, and risk management, while fostering a culture of continuous

Qualifications

• Bachelor's degree in a scientific or technical discipline is required.
• 7+ years of Quality experience within GMP-regulated environments.
• Prior leadership or people management experience preferred.
• Strong understanding of Quality Systems and regulatory requirements.
• Experience supporting audits, inspections, supplier quality, validation, and compliance programs.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work effectively with internal and external stakeholders.

Responsibilities

• Lead and develop Quality personnel supporting compliance and quality systems activities.
• Oversee quality programs related to audits, supplier quality, validation, and regulatory compliance.
• Support inspection readiness efforts and assist with responses to regulatory inquiries.
• Manage quality agreements and compliance-related documentation.
• Partner with cross-functional teams to ensure alignment with quality and business objectives.
• Review quality metrics and identify opportunities for process improvement.
• Support investigations, CAPAs, change controls, and risk management activities.
• Foster a culture of quality, compliance, and continuous improvement.

Skills

Quality systems

Regulatory compliance

Leadership

Audits & inspections

CAPA & change control

Risk management

Education

Bachelor's degree in scientific or technical discipline

Job description

Our client is seeking a Quality & Compliance Manager to oversee quality systems, compliance initiatives, and regulatory activities within a GMP-regulated pharmaceutical or biotechnology environment. This position will provide leadership across quality operations and serve as a key partner to internal stakeholders to ensure adherence to quality standards and regulatory requirements. The role offers an opportunity to drive continuous improvement, support inspection readiness, and strengthen quality processes across the organization.

Responsibilities

• Lead and develop Quality personnel supporting compliance and quality systems activities
• Oversee quality programs related to audits, supplier quality, validation, and regulatory compliance
• Support inspection readiness efforts and assist with responses to regulatory inquiries
• Manage quality agreements and compliance-related documentation
• Partner with cross-functional teams to ensure alignment with quality and business objectives
• Review quality metrics and identify opportunities for process improvement
• Support investigations, CAPAs, change controls, and risk management activities
• Foster a culture of quality, compliance, and continuous improvement

Qualifications

• Bachelor's degree in scientific or technical discipline
• 7+ years of Quality experience within a GMP-regulated pharmaceutical, biotechnology, or medical device environment
• Prior leadership or people management experience preferred
• Strong understanding of Quality Systems and regulatory requirements
• Experience supporting audits, inspections, supplier quality, validation, and compliance programs
• Excellent communication, organizational, and problem-solving skills
• Ability to work effectively with internal and external stakeholders