Manager, Quality and Compliance

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