Associate Director, Quality Management Systems
$160,000–$195,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
Lead the evolution of a global Quality Management System into a commercial-ready, scalable framework aligned with ICH Q10 and FDA CFRs. Oversee end-to-end lifecycle management of quality documents, policies, and SOPs while driving high-volume authoring and revision under accelerated timelines. Establish and sustain a proactive compliance model that ensures continuous inspection readiness, serving as the primary representative during regulatory interactions. Manage the planning, deployment, and governance of role-based training curricula and learning programs, including the design of engaging materials and technical sessions to scale eDMS and LMS capabilities. Define, monitor, and report quality metrics to assess system health and drive continuous improvement initiatives to enhance efficiency and reduce risk. Partner cross-functionally to embed quality into business processes, communicate risks with clarity, and lead the implementation of validated eQMS platforms.
Required Qualifications
- Bachelor's degree in a scientific discipline or Quality Systems Management
- 8+ years of experience in biotechnology or pharmaceutical environments
- Demonstrated experience with direct ownership of QMS and quality systems
- Deep understanding of global regulatory requirements, including FDA CFRs, ICH guidance, and EU Annex requirements
- Proven experience implementing and managing eQMS platforms (e.g., Veeva eQMS, MasterControl) and Learning Management Systems
- Strong strategic and operational capability, balancing vision-setting with hands-on execution
- Proven ability to manage multiple complex initiatives in a fast-paced, dynamic environment
- Strong judgment and risk management skills, balancing compliance, science, and business needs
- Exceptional written and verbal communication skills with the ability to influence senior and cross-functional stakeholders
- Highly proactive, accountable, and comfortable operating with a high degree of autonomy
- Exposure across GxPs (GCP, GLP, GMP, GVP)
Desired Qualifications
- advanced degree
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