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Associate Director – Quality Systems
Landmark Bio. Own the strategy, design and continuous improvement of the Quality Management System .
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Own the strategy, design and continuous improvement of the Quality Management System
- Establish and maintain the quality manual, quality policies and governing procedure hierarchy
- Own core quality systems including documentation management, training, deviations, CAPA, effectiveness checks, change control, supplier quality and change management, quality risk management, and audit management
- Implement a quality risk management program consistent with ICH Q9(R1)
- Ensure compliance with applicable regulations and guidance documents
- Lead supplier, client and internal audit readiness programs
- Support front-room and back-room audits and oversee audit responses
- Own the internal audit program, including annual planning, execution, reporting and CAPA follow-up
- Oversee supplier qualification and monitoring, including risk-based supplier audits and performance management
- Define, trend and report key quality metrics and indicators
- Lead quality management reviews and escalate significant compliance risks to senior leadership
- Build, lead and develop the Quality Systems team, including recruiting, performance objectives, coaching and career development
- Manage and own the Change Control Review Board
- Partner with cross-functional stakeholders to foster a strong Culture of Quality
- Drive timely closure of quality records
Requirements
What you’ll need- Minimum Bachelor’s degree in STEM, such as biology, chemistry and engineering
- 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
- Subject matter expertise in Quality Systems in a GMP biotech setting
- Preferred experience with Veeva Vault
- Relevant phase-appropriate GMP experience
- Preferred ASQ certification
- Ability to stand, perform light lifting, and wear PPE when required
- Submit a resume/CV and brief cover letter describing relevant experience
Benefits
Comp & perks- Equal Opportunity, Affirmative Action employer
- Minorities, women, veterans, and individuals with disabilities are encouraged to apply
- Hybrid work arrangement with 3 days on site per week
- Monday–Friday administrative hours
- No travel required