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.
$175,000 - $215,000 a year
