Director of Quality Compliance

Responsibilities

• Supplier Qualification & Vendor Management: 
• Develop and implement a supplier qualification strategy to assess and monitor external partners, contract manufacturing organizations (CMOs), and contract service providers (CSPs). 
• Create a risk-based audit and supplier assessment strategy to support clinical program timelines and operational goals. 
• Lead supplier qualification audits and manage internal and external auditors to ensure compliance with GxP and regulatory requirements. 
• Collaborate with procurement, manufacturing, and technical teams to evaluate supplier performance and support vendor risk management processes. 
• Establish and maintain supplier quality agreements, defining expectations for compliance and quality standards. 
• Independently manage domestic and international audits and lead efforts for continuous improvement of quality systems. 


• Compliance Risk Management & Quality Assurance: 
• Identify, assess, and manage compliance risks across internal operations and external partnerships. 
• Design and execute a risk-based quality management system (QMS) aligned with regulatory requirements and industry best practices. 
• Oversee the development and implementation of corrective and preventive actions (CAPA) to address quality issues and mitigate risks. 
• Ensure ongoing monitoring and continuous improvement of quality compliance processes and systems. 


• Inspection Readiness & Audit Management: 
• Lead the organization’s inspection readiness program to prepare for FDA, EMA, and other health authority inspections. 
• Conduct mock audits, inspection training, and readiness assessments to support teams across clinical, manufacturing, and technical operations. 
• Serve as the primary point of contact during regulatory inspections and ensure rapid resolution of any inspection findings. 
• Manage internal audits to ensure compliance with GxP and regulatory expectations. 


• Cross-Functional Collaboration & Leadership: 
• Collaborate closely with manufacturing, regulatory affairs, clinical operations, and external partners to align quality objectives with operational goals. 
• Provide guidance on GxP requirements and regulatory changes, ensuring they are integrated into business operations. 
• Build, lead, and mentor a high-performing quality assurance team, fostering a culture of excellence and continuous improvement. 


• Operational Excellence & Compliance 
• Collaborate with cross-functional teams (Manufacturing, Clinical Operations, Regulatory Affairs) to identify risks and implement corrective and preventive actions (CAPAs). 
• Define and maintain policies, procedures, and processes aligned with best industry practices and regulatory requirements. 
• Lead investigations into critical quality issues and product complaints, driving root cause analysis and CAPA implementation. 
• Monitor evolving regulatory landscapes (FDA, EMA, ICH) to ensure company processes remain compliant with global standards. 
• Promote a culture of continuous improvement and sustainable compliance throughout the organization. 

Qualifications

• Advanced degree in Life Sciences, Pharmacy, or related field. 
• 10+ years in GxP compliance and quality management within the biotechnology or pharmaceutical industry. 
• Experience with autologous/allogeneic cell therapy or genetically modified products is strongly preferred. 
• In-depth knowledge of FDA, EMA regulations, and ICH guidelines, particularly those related to cell-based therapies. 
• Track record of managing quality systems across product lifecycles, including preparation for health authority inspections. 
• Strong leadership in matrix environments with experience influencing cross-functional teams. 
• Expertise in problem-solving, strategic thinking, and risk management. 
• Exceptional verbal and written communication, with the ability to present complex topics to stakeholders at all levels. 
• Self-starter who thrives in collaborative environments, with the ability to build strong relationships based on trust and transparency.