Senior Director, R&D QA

Position Summary:

The Senior Director of R&D Quality Assurance is responsible for establishing and implementing the strategy for the R&D QA function that provides Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practices (GLP) quality oversight at Apellis. The individual will partner with senior management and stakeholders to develop risk-based, phase-appropriate strategies to ensure that clinical trials and post-approval activities are conducted in compliance with applicable regulations, ICH guidelines, and industry best practices.

Key Responsibilities Include:

• Provide overall R&D QA leadership and strategic development for global R&D QA activities at Apellis, its investigator sites and external service providers to ensure implementation of quality and compliance initiatives for global Phase I - IV clinical studies and marketed product, including establishment and maintenance of phase appropriate quality systems for drug, devices, and combination products.
• Partner cross functionally to enable transparency & escalation of R&D quality risks and issues, collaborating to address challenges and constraints. Provide risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks
• Establish strong partnership with senior leaders and key stakeholders, fostering a commitment to quality and a culture of quality. Interface with key external Quality organizations for development vendors and partners.
• Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
• Assist in the implementation of compliant procedures and operations to ensure a robust quality management system for the conduct of clinical studies and marketed pharmaceutical/medical device combination products.
• Serve as a resource to global clinical and safety personnel on compliance issues, preparations for external inspections, regulatory risk, and process improvement opportunities. Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
• Review regulatory and corporate compliance risks, altering senior management when needed.
• Assure global regulations are followed for clinical trial and marketed product reporting, including submission of adverse events/SAE reporting and all required clinical reports.
• Assure personnel, documentation (protocols, reports, device labeling, promotional and advertising materials), processes and quality standards meet expectations for regulatory submissions, regulatory authority inspections, and compliance with applicable regulations and guidelines.
• Develop and oversee appropriate Quality metrics and reporting on the state of Apellis' compliance to senior management regarding critical quality and compliance related issues and corrective actions to mitigate risk.
• Assure the quality and integrity of the results from raw data protocols and reports are in compliance with investigational plans, policies, procedures, and applicable government regulations.
• Deliver leadership and technical direction in preparation and hosting of Health Authority Inspections (BIMO, PADE, REMS, etc.) internally, at clinical sites, and at CROs, including follow-up efforts, to ensure successful outcomes and responses to any observations.
• Host GCP and GVP regulatory inspections at Apellis. Lead/oversee management of internal inspection readiness activities throughout program life cycle for study teams
• Direct the internal and external R&D audit programs, including the development of audit plans, priorities and schedules.
• In collaboration with functional area leaders, ensure clinical and pharmacovigilance service providers comply with the applicable quality program and regulations/guidelines.
• Develop and implement Study-Specific Audit Plans and Quality Risk Management Plans for clinical trials.
• Oversee R&D QA incident investigations, including input and approval of plans for resolution of Quality issues including but not limited to the assessment of serious breaches, partnering with internal and external stakeholders to ensure CAPAs are appropriate and effective.
• Proactively provide consultative R&D QA support to global clinical development activities to protect patient safety, maintain data integrity, and support operational efficiency.
• Function as a member of the Quality Leadership Team (QLT), responsible for establishing the organizational strategy, resource and capacity planning, culture building, talent management, and stakeholder engagement.
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