There is a life sciences revolution occurring being driven by the tremendous demand for cell and gene therapies. This demand coupled with the desire for collaboration, the availability of capital, regulatory mind shifts, technological developments, and bottlenecks in supply chains are creating tremendous opportunities for first movers and service providers. The Discovery Labs platform supports and drives this new environment by creating space for CGT Manufacturing, Research and Discovery and the all supporting services.
The Discovery Labs is seeking an experienced Director of Quality Systems to play a critical role in delivering a Quality Management System (QMS) that enables innovation, productivity, continuous improvement, and adherence to applicable regulations. The Director of Quality Systems will be responsible for building impactful relationships and collaborations across the organization while relying on practical experience to advance a proactive and quality beyond compliance strategy in a fast-paced organization.
• Provide hands-on expertise in the day-to-day managing of data and document control including all aspects of quality management – change control, deviations, investigations, and CAPA.
• Monitor the overall quality system effectiveness – continuous improvements, trending beyond metrics, lessons learned/knowledge management, and striving for operational excellence.
• Lead and/or participate in Agency Inspections and Client Audits
• Develop a virtual audit program, including a virtual tour and secure document sharing
• Coordinate and provide training in support of the QMS e.g. GMP, GDP, Root Cause Analysis
• Actively participate and lead the preparation of Quality Management Reviews and Quality Improvement plans.
• Propose, initiate and prepare SOPs and other governance documents.
• Review, approve and/or administer critical compliance documents in support of GMP, GTP and GCP operations according to The Discovery Labs, Center for Breakthrough medicines SOPs and regulatory requirements. This may include test specifications, batch record reviews, stability monitoring, authorizations to ship.
• Perform vendor/CRO/CDMO audits and oversight.
• Develop and implement an Internal Audit, Mock Agency Inspection, and QA Shop Floor program, focusing on compliance and audit readiness
• Collaborate with other subject matter experts across the GMP organizations to conduct cross-functional investigations, risk management and mitigation plans.
• Represent Quality at designated cross-functional project/program team meetings.
Education & Experience
Bachelor’s Degree in Life Sciences.
• Ten+ years of relevant Quality experience including managing GXP quality systems in the Pharma/Biotech industry.
• Solid understanding of industry regulation 21CFR 210, 211, 11, 820 as well as EU Guideline for Advanced Therapy and Medicinal Products.
• Significant experience with both digital and paper based QMS solutions.
• Diverse, Quality operations experience across functions in GMP including CRO/CDMO oversight activities.
• Regulatory experience a plus.