Inozyme is looking for an experienced Senior Director / Director, Quality and GCP Compliance professional to join our exciting, fast-paced organization to provide hands-on leadership, development, and management of Inozyme’s GCP Quality Programs including direct oversight of Inozyme’s GCP site / vendor qualification and audit programs. This position will report to and partner with Inozyme’s Vice President of Quality and Compliance to develop and execute the Quality Plan.
The candidate must be an outgoing, strategic thinker with excellent communication skills; motivated to inspire and lead others to achieve the critical mission of the Quality function.
- Serve as Inzoyme’s Quality Assurance expert on all matters of GCP compliance.
- Create / develop relevant SOPs for ensuring operational compliance to GCP.
- Partner with Inozyme’s Clinical Operations Compliance Lead and other stakeholders within Clinical Operations, BioStats and Medical to ensure GCP inspection readiness within the Inozyme clinical organization and Inozyme’s study investigator sites.
- Review relevant sections of BLA submissions to ensure data and documents comply with GCP guidelines. Perform QC checks of relevant clinical documents and regulatory dossiers, e.g., Investigator's Brochure, CRF, Clinical Study Reports to ensure data integrity and accuracy.
- Provide Quality oversight / management to investigations into significant clinical quality events (e.g., suspected serious breach, compromised data integrity, and other critical departures to GCP). Work with cross functional SME’s and stakeholders to ensure identification of root cause and CAPA. Track CAPA implementation and effectiveness; ensures reporting requirements to applicable regulatory bodies are met as applicable.
- Develop internal reports / dashboards with meaningful quality performance metrics to be shared with relevant Department Heads and presented to Inozyme Executive Management with recommendations for corrective / preventive actions where appropriate.
- Develop and manage risk-based GCP vendor and clinical site qualification program. Manage the audit program; coordinate with 3rd party contract auditors including scheduling, audit preparation, responses, and report closure.
- Attends regular clinical project team meetings to provide QA presence, oversight and support.
Requirements and Qualifications:
- 15+ years experience performing Clinical Quality Assurance functions (GCP) for clinical studies including audit of clinical investigators and CROs / vendors.
- Self-motivated individual with ability to handle multiple priorities to meet project team goals and timelines.
- Experience in implementing GCP inspection readiness program, including mock inspection activities.
- Experience conducting quality audits of CROs and investigational clinical sites.
- Extensive experience/expertise effectively managing GCP related major / critical deviations, CAPA and product complaints to meet regulatory expectations and compliance to Inzoyme procedures.
- In-depth knowledge of FDA, EMA and ICH regulatory requirements related to GCP quality compliance.
- Demonstrated management/supervisory experience with a history of developing a culture of quality / compliance awareness, teamwork and collaboration.
- Estimated 10% travel required.
- Minimum bachelor’s degree in Life Sciences
- 15+ years of experience with GCP focused responsibilities.
- 5+ Years prior management experience of 2-5 direct reports preferred.