Director, Quality Assurance & Quality Systems

Responsibilities

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 

Requirements

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 

Work Environment / Physical Demands

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.