Director / Senior Director, Quality and Compliance
Inozyme is looking for an experienced Senior Director / Director, Quality and Compliance professional to join our exciting, fast-paced organization to provide hands-on leadership, development, and management of Inozyme’s Quality Management Systems (QMS) to support ongoing clinical studies, biopharmaceutical product development and product registration. This role will involve building and establishing the Inozyme eQMS platform to support Sponsor Quality oversight and managing suppliers contracted for GLP/GMP/GCP activities. The ideal candidate will possess and leverage their prior Quality management experience and expertise spanning GMP and GCP operations to provide appropriate risk-based scientific approaches to quality control and decision-making. Previous Quality management experience operating within product Sponsor / Innovator and CDMO organizations is highly desirable.
The Senior Director / Director of Quality and Compliance will report to and partner with Inozyme’s Vice President of Quality and Compliance to develop and execute the Quality Plan while able to work independently with CMC and Clinical Operations to ensure the consistent and meaningful application of Inozyme QMS requirements and principles to achieve GXP compliance. The candidate will ensure conformance with international and domestic quality system standards and best practices, including but not limited to 21 CFR parts 11, 312, 210, 211, and 600, EudraLex volume 3, and ICH Quality Guidelines.
The candidate must be an outgoing, strategic thinker with excellent communication skills and motivated to inspire and lead others to achieve the critical mission of the Quality function.
Education and Qualifications:
- Minimum bachelor’s degree in Life Sciences
- 10+ years of experience in a GMP/GCP environment.
- 5+ Years prior management experience of 2-5 direct reports preferred.
- Proficiency with Quality management software and EDMS platforms (e.g., eTMF, MasterControl, Veeva, ZenQMS, TrackWise, etc.).
Requirements:
Skills / Experience:
- Prior experience with quality management and oversight of GLP/GMP/GCP operations from an outsourced and insourced business model is highly desirable.
- Prior experience providing Quality Assurance functions to clinical operations to ensure GCP compliance.
- Extensive knowledge and experience of FDA/EMA regulatory requirements and expectations for operational compliance with GMP and GCP.
- Experience working with external vendors to provide the Sponsor quality oversight to GMP batch manufacturing readiness and batch disposition for Drug Substance and sterile Drug Product.
- Direct experience establishing/managing a risk-based supplier qualification program, including the ongoing oversight and monitoring of supplier performance.
- Experience with conducting, managing, and tracking supplier audits.
- Extensive experience/expertise in effectively managing deviations, CAPA, change control, and product complaints to meet regulatory expectations while adhering to assigned timelines.
- Strong ability to communicate effectively with all levels of the organization within and outside of the department, including external vendors.
- Excellent organizational skills, analytical and problem-solving abilities, and strong verbal and writing skills.
- Ability to lead, motivate, and educate others on matters of quality compliance. Able to communicate the meaningful rationale behind Inozyme quality requirements to promote a culture of quality awareness and appreciation for the value of quality compliance to the Inozyme organization and the patients enrolled in Inozyme clinical studies.
- Able to operate in a dynamic, fast-growing biotech company with aggressive timelines.
Essential Duties and Responsibilities:
Quality Management Systems (40%)
- eQMS Maintenance and Support: Take primary responsibility for upholding and optimizing the electronic Quality Management System (eQMS) in compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP).
- SOP Management: Oversee the change control, creation, and implementation of Standard Operating Procedures (SOPs) across all levels of GXP compliance.
- Training Programs and Curricula: Develop and manage training programs, including curricula tailored to GXP requirements.
- Deviation and Complaint Handling: Manage the investigation, documentation, and resolution of deviations and product complaints, ensuring timely closure.
- Quality Dashboard Development: Create and maintain dashboards to be presented at Quality Management Review meetings, capturing key metrics and performance indicators.
- CAPA Management: Lead the Corrective and Preventive Actions (CAPA) process, including tracking overdue deviations and resolving them promptly.
Audit Plan Maintenance (25%)
- Develop, maintain, and execute an internal and external audit plan in line with GXP requirements using Risk Based principles.
- Vendor List Management: Maintain an up-to-date and approved vendor list, ensuring each supplier’s quality measures meet the company's requirements.
- Audit Findings Management: Oversee the process of reviewing and closing out audit findings, including the development and execution of action plans.
QA Review of Mastered and Executed GMP Batch Documentation to Support Batch Disposition (20%)
- Work with internal stakeholders and vendors to ensure effective Quality review and approval of documentation to support GMP production and batch disposition.
- IMP Label Review: Support review of master labels for Investigational Medicinal Products (IMP) to ensure all regulatory standards are met and aligned with regulatory submissions.
- Clinical Site Sub-Lot Releases: Coordinate Batch review/Drug Product release to facilitate the timely and compliant release of sub-lots to clinical sites.
Clinical Compliance and Inspection Readiness (15%)
- Quality Oversight in Clinical Trials: Assume primary responsibility for Quality oversight of global clinical trials, covering phases 1-3. Work closely with the clinical study teams to ensure compliance with regulations and guidelines.
- GCP and GMP Pre-Approval Inspections (PAI): Prepare for and maintain a state of readiness for Pre-Approval Inspections (PAI) related to Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).
- Collaboration with Clinical Teams: Actively engage with clinical study teams to develop and implement strategies for inspection readiness, ensuring that all aspects of clinical operations are conducted under good GCP practices.
Able to be onsite 3 - 4 days weekly (additional as needed) in our Boston office location.
Able to travel as necessary up to 10%
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