About this role
Scope of Responsibilities
- Own the strategy, design and continuous improvement of the Quality Management System, ensuring it is phase-appropriate, scalable and aligned with company growth from early clinical through late-stage development.
- Establish and maintain the quality manual, quality policies and the governing procedure hierarchy.
- Serve as the process owner for core quality systems including
- Documentation Management
- Training
- Deviations, CAPA, Effectiveness Checks
- Change Control
- Supplier Quality and Change Management
- Quality Risk Management
- Audit Management, including Supplier, Client and Internal
- Implement a quality risk management program consistent with ICH Q9(R1), and embed risk-based decision making across Quality and operational functions.
- Ensure compliance with applicable regulations and guidance documents
- Lead the company’s supplier, client and internal audit readiness program
- Support front-room or back-room audits, oversee timely and high-quality audit responses
- Own the internal audit program, including annual audit planning, execution, reporting and CAPA follow-up
- Oversee supplier qualification and monitoring program, including risk-based supplier audits and performance management
- Define, trend and report key quality metrics and indicators to identify systemic risks and improvement opportunities
- Lead the quality management review process and escalate significant compliance risks to senior leadership
- Build, lead and develop high-performing Quality Systems team, including recruiting, setting performance objectives, coaching and planning career development discussions
- Manage and own the Change Control Review Board
- Partner with internal cross-functional stakeholders to foster a strong Culture of Quality, promoting shared accountability for compliance and right-first-time performance
- Influence internal cross-functional stakeholders to drive timely closure of quality records
Required Experiences
Education
- Minimum Bachelor’s degree is STEM, such as biology, chemistry and engineering
Experience
- 8+ years of Quality experience working in a GMP biotechnology manufacturing environment, ideally with hands-on experience in cell and/or gene therapy
- 5+ years of effective management and strong leadership experience
Knowledge & Skills
- Subject matter expertise in Quality Systems in a GMP biotech setting
- Preferred experience with Veeva Vault
- Relevant phase-appropriate GMP experience
Preferred Qualifications
- Preferred ASQ certification
Physical / Work Requirements
- Work environment: Office
- On-site expectations: 3 days on site per week
- Physical requirements: Standing, light lifting, ability to wear PPE when required
- Travel: None
- Schedule requirements: Monday – Friday, administrative hours
- Other requirements: N/A
To Apply
Please submit your resume/CV along with a brief cover letter describing your relevant experience for one or more applicable areas indicated above.