Director, Global Quality Management System & Risk Management

Position Summary:

The Director, Global Quality Systems (QMS) & Risk Management is a key leadership role within Global Quality Operations, responsible for setting the strategic direction and ensuring operational excellence across core quality system areas: QMS & Risk Management; Product Complaints; Quality Events (Deviation, CAPA, Change Control); and Digital QMS Governance. This role provides strategic oversight and execution of quality systems that ensure compliance with global regulatory requirements, support continuous improvement, risk management, and align with business objectives. The Director will be responsible for cross-functional governance, monitor and enhance key quality and corporate metrics, and drive data-informed decision-making through robust analytics and trending. With accountability for the digital QMS roadmap and quality systems lifecycle, this leader will shape scalable, solutions and improvements that enable stakeholder adoption, and a proactive quality culture. The Director will serve as a business owner, cross-functional collaborator, and subject matter expert—ensuring quality processes remain aligned, agile, and effective in supporting global operations.

Key Responsibilities Include:

QMS & Risk Management Oversight

• Responsible for the cross-functional QMS Process, Record and Change Owners governance, promoting collaboration and system-wide consistency.
• Direct the Quality Management Review (QMR) program, including development of key metrics, dashboards, and actionable readouts.
• Monitor and manage the assessment of regulatory changes to proactively adjust the QMS strategy and maintain compliance and manage risk.
• Own the performance of key QMS metrics and partner across functions to ensure achievement of quality objectives.
• Align QMS strategies with business needs and act as a key liaison between Quality and cross-functional departments.

Quality Events (Deviation, CAPA, and Change Control Management)

• Provide strategic and operational leadership of the global deviation, CAPA, and change control programs.
• Establish and maintain robust, fit-for-purpose processes, workflows, and digital tools for managing Quality Events.
• Oversee governance forums and provide oversight to ensure consistency, timely closure, and effectiveness of root cause investigations and CAPAs.
• Develop and maintain analytics and trending dashboards to identify systemic issues and drive continuous improvement and risk management.
• Ensure timely fulfillment of inspection and audit-related commitments within the QMS.

Product Complaints Management

• Provide strategic and operational leadership for the global Product Complaints program, ensuring timely triage, thorough investigation, risk assessment, and resolution in alignment with regulatory and business requirements.
• Oversee the governance structure, including triage boards and complaint review committees, to drive accountability, ensure cross-functional collaboration, and maintain consistency in decision-making and escalation processes.
• Ensure end-to-end procedural compliance, from intake through closure, by establishing and monitoring robust processes, quality records, and system controls across all complaint handling stages.
• Drive the development and execution of complaint trending and analytics, identifying signals, systemic issues, and areas for continuous improvement, while ensuring readiness for regulatory inspections and external audits.
• Collaborate with internal partners and external stakeholders to assess product impact and enable timely, effective responses to potential risks.
• Support global reporting and market-specific requirements in alignment with regulatory reporting obligations and timelines.
• Maintain an inspection-ready at all times through proactive governance, training, periodic audits, and continuous enhancement of the complaint handling framework.

 Additional Responsibilities

• Oversee the digital QMS governance model and roadmap to support activities across all eQMS systems phases, ensuring alignment with business needs.
• Oversee the organizational training and support for global quality system processes.
• Establishes a communication strategy for QMS Support, key messages, and management of escalations.
• Ability to think strategically and maintain attention to detail.
• Lead, develop, and mentor a team of quality professionals responsible for key QMS elements, fostering a culture of accountability, collaboration, and continuous improvement.
• Serve as a subject matter expert and leader during inspections and audits.
• Manage contracts and budgets as needed. 

Education, Registration & Certification:

• Master's or bachelor's degree. 

Experience:

• 10+ years of experience in early or late-phase clinical research or a GxP-regulated environment and 6+ years' experience quality in GxP environments.

Skills, Knowledge & Abilities:

•  A hands-on leader with 3 to 5 years of managerial experience who leads by example, inspires and empowers team members.
• Strong experience within CAPA, Deviations, and Change Controls processes, oversight, and trending.
• Strong knowledge of GxPs (GLP, GMP, GCP, GPvP) and applicable analytical needs.
• Managing risk management and oversight program.
• Proactive in identifying opportunities with a robust solution minded approach and flexibility to emerging challenges.
• Strong collaborative, influencing, and interpersonal skills with excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management.
• Ability to prioritize competing activities and manage resources and budget accordingly.
• Ability to maintain and create professional networks with stakeholders internally and externally.
• Ability to understand and translate customer needs for innovative and creative approaches to quality management.

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 20% travel expected. 

Benefits and Perks:

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit https://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

 EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.  

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.