Quality Assurance Operations Manager
Quality Assurance Operations Manager
Our client is seeking a Quality Assurance Operations Manager to provide leadership and oversight for Quality activities supporting GMP manufacturing operations within a biologics environment. This position will play a critical role in ensuring regulatory compliance, operational excellence, and continuous improvement across manufacturing and quality functions.
The ideal candidate will collaborate with cross-functional stakeholders to support production activities, review manufacturing documentation, manage quality events, and maintain compliance with applicable regulatory requirements. This is an excellent opportunity for an experienced Quality professional to join an innovative organization focused on advancing biologic therapies.
Key Responsibilities
- Provide leadership, coaching, and development for Quality Assurance personnel
- Ensure Quality oversight of manufacturing processes and GMP operations
- Review and approve manufacturing records and support release-related activities
- Partner with operational teams to investigate and resolve quality events, including deviations and CAPAs
- Support implementation of process improvements and operational excellence initiatives
- Maintain inspection readiness and support internal and external audits
- Collaborate with Technical Operations, Quality Control, and other functional groups to ensure compliance objectives are achieved
- Contribute to quality risk management and continuous improvement programs
- Foster a strong culture of quality and compliance throughout the organization
Qualifications
- Bachelor's degree in scientific discipline
- 8+ years of experience in Quality Assurance within a GMP-regulated environment
- Previous experience leading or mentoring Quality professionals
- Strong understanding of Quality Systems and regulatory requirements governing biologics or pharmaceutical manufacturing
- Experience supporting investigations, changing management, CAPAs, and documentation review
- Excellent communication, collaboration, and problem-solving skills
- Working knowledge of global regulatory expectations, including FDA and international GMP requirements
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