Director, Quality Assurance & Quality Systems

Quality Assurance & Quality Systems Leadership 

• Lead and manage the QA/QS team, ensuring alignment with company objectives and regulatory standards 


• Develop, implement, and maintain quality management strategies and systems to ensure compliance with GMP, FDA, ICH guidelines, and other relevant regulatory bodies 


• Design, establish, and continuously improve the Quality Management System (QMS), including document control, change control, training systems, and electronic quality systems (eQMS) 

Quality Systems Management 

• Oversee the entire quality systems infrastructure, including Standard Operating Procedures (SOPs), batch records, specifications, and validation protocols 


• Manage document lifecycle management ensuring version control, approval workflows, and archival in compliance with regulatory requirements 


• Establish and maintain quality metrics dashboards and Key Performance Indicators (KPIs) for system effectiveness 

Compliance & Regulatory 

• Establish and enforce quality assurance policies and procedures across all operational departments 


• Support the preparation and execution of internal audits, including regulatory inspections, to ensure compliance with regulatory requirements 


• Ensure timely resolution of quality-related issues, including non-conformances, deviations, and CAPA (Corrective and Preventive Actions) 


• Maintain inspection readiness and serve as primary QA point of contact for regulatory inspections 

Cross-Functional Collaboration & Lifecycle Management 

• Collaborate with cross-functional teams (R&D, manufacturing, regulatory affairs, supply chain, etc.) to ensure product quality throughout the entire lifecycle 


• Partner with Regulatory Affairs to support CMC sections of regulatory submissions (IND, BLA, NDA) 


• Support technology transfer activities and new product introductions from a quality systems perspective 

Continuous Improvement & Risk Management 

• Lead continuous improvement initiatives leveraging methodologies to enhance product quality, manufacturing processes, and operational efficiency 


• Provide leadership in Quality Risk Management (QRM), including identification, assessment, and mitigation of quality risks using ICH Q9 principles 


• Champion a culture of quality throughout the organization 

Performance Management & Reporting 

• Prepare and present quality performance metrics, trending analysis, and reports to senior management and board of directors 


• Mentor and develop QA/QS staff, fostering a culture of accountability, compliance, and continuous professional growth 

Education & Experience 

• Bachelor's degree in Life Sciences, Engineering, or a related field (Master's degree preferred) 


• 10+ years of progressive experience in Quality Assurance and Quality Systems, with at least 5 years in a leadership role within a regulated industry (pharmaceutical, biotechnology, or medical devices) 


• Direct experience in cell and gene therapy or advanced therapeutic products is highly desirable 

Technical Knowledge 

• Strong knowledge of regulatory requirements, including FDA, GMP, ICH guidelines, ISO 13485, and 21 CFR Parts 210, 211, 600, 820, and 1271 


• Demonstrated expertise in Quality Management Systems (QMS) design, implementation, and maintenance 


• Proven experience with electronic quality systems (eQMS) platforms (e.g., Veeva, MasterControl, TrackWise, or similar) 


• Knowledge of Quality Risk Management methodologies (ICH Q9, FMEA, etc.) 

Leadership & Management 

• Proven experience leading quality assurance and quality systems teams and managing cross-functional collaborations 


• Demonstrated ability to drive process improvements and manage complex quality systems in dynamic environments 


• Experience managing regulatory inspections and audit readiness programs 

Skills & Competencies 

• Excellent problem-solving, analytical, and decision-making skills 


• Strong written and verbal communication skills, with the ability to interact with senior leadership, regulatory agencies, and external stakeholders 


• Experience in preparing and presenting reports and metrics to senior management and board members 


• Strong leadership and interpersonal skills, with the ability to mentor and guide teams towards excellence 


• Ability to work effectively in a fast-paced, entrepreneurial environment with changing priorities 

• Primarily office-based with required time in GMP spaces addressing quality management and audits. 


• Requires prolonged periods of computer use for documentation, data analysis, and report generation related to quality processes. 


• May involve lifting office materials or equipment up to 10 pounds. 


• Ability to navigate office and GMP environments for audits and oversight.