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