Opportunity awaits those up to the challenge of developing transformative therapies across a broad range of debilitating diseases.
Summary:
This role leads global quality operations for clinical and commercial products, overseeing CMOs and external partners across intermediates, drug substance, drug product, and finished goods to ensure supply and regulatory compliance.
This role sets global quality operations strategy, resolves issues, strengthens quality systems, and builds team capability to support business and pipeline needs.
This role oversees quality operations for imports, market release, wholesale distribution, and safe trading of medicinal products.
This role ensures phase-appropriate GMP/GDP quality assurance across all relevant territories including but not limited to US, the EU/EEA, and Australia, ensuring products are manufactured, released, and distributed in line with regulations and company procedures.
The role builds country quality functions and regional structures to support product release, commercial strategy, and launches.
The role serves as a liaison between international affiliates and Apellis Pharmaceuticals Inc., ensuring alignment with the global quality system and local requirements.
The role oversees routine GMP batch production for intermediates, drug substance, and drug product managed under Apellis Inc and Apellis International GmbH.
The role may train and qualify staff and delegate tasks as needed.
Roles and Responsibilities:
- Provides strategic and operational oversight to ensure timely market release, reliable supply, and safe trading of high-quality medicinal products, including direct technical supervision of GxP activities.
- Serves as the Quality GxP Lead and acts as Apellis’ senior Quality leader for the international region, defining strategy and supporting continued global growth and expansion.
- Develops and leads the international Quality organization in close alignment with Global Quality, including build-out of affiliate quality structures and oversight of global quality operations supported by a unified GMP/GDP QMS.
- Ensure implementation, maintenance, and continuous improvement of the Quality Management System, including risk identification, escalation of critical quality issues (e.g., complaints, recalls, counterfeits), and inspection readiness.
- Maintains end-to-end GMP/GDP oversight of intermediates, drug substance, and drug product under Apellis Inc and Apellis International titles, ensuring compliant manufacturing, certification, release, storage, distribution, and full batch traceability.
- Oversee qualification, management, and auditing of Contract Manufacturing Organizations (CMOs) and Contract Service Providers (CSPs), including establishment of quality agreements and periodic requalification.
- Ensures appropriate controls for product handling and distribution, including validated storage conditions, and investigation of deviations such as temperature excursions and security breaches, with regulatory notification as required.
- Leads batch certification and release activities, ensuring required documentation (e.g., CoA) is reviewed, approved, and archived, and that only compliant batches are released.
- Represents Quality in inspections and audits, supports vendor audit programs, and ensures effective self-inspection and Quality Management Review processes.
- Collaborates cross-functionally with Regulatory, Supply Chain, and other stakeholders to support business objectives and product lifecycle activities.
Requirements
Education, Registration, Advance Training &/or Certifications:
Master’s degree in science or pharmacy
Experience, Expert Knowledge &/or Competencies:
- In-depth knowledge of applicable regulations and guidelines, including but not limited to 21 CFR 11, 210, 211, Swiss Medicinal Products Licensing Ordinance (SR 812.212.1), EU GMP (EudraLex Volume 4; notably Annexes 1, 13, and 16), and GDP requirements for medicinal products and active substances.
- Strong expertise in U.S., European and international regulatory frameworks, ensuring full compliance across import, export, and foreign trade activities, including end-to-end supply chain adherence to GDP requirements.
- Extensive experience in batch disposition and certification, including importation into the EU.
- Proven leadership in Quality Systems management, including inspection readiness and global QMS alignment.
- Demonstrated expertise in deviation and non-conformance management, including root cause analysis and CAPA implementation.
- Track record in driving systematic process improvements and continuous quality enhancement initiatives.
Experience & Competencies
- Leadership & Organizational Development: Proven ability to lead and develop high-performing, diverse teams, effectively navigating different working styles and driving collaboration across a global matrix organization.
- Strategic & Operational Leadership: Defines and executes aligned quality strategies, gaining commitment from internal and external stakeholders to deliver key business objectives.
- Results Orientation & Execution: Strong analytical mindset combined with a proactive, action-oriented approach to resolve complex issues, make sound decisions, and deliver against critical timelines.
- Resilience & Adaptability: Demonstrates high adaptability in dynamic environments, with the ability to distill complex issues to their core and propose clear, decisive solutions.
- Patient & Stakeholder Focus : Maintains a strong patient-centric mindset while understanding and anticipating the needs of internal and external stakeholders, fostering a culture of quality and excellence.
- Critical Thinking & Continuous Improvement: Applies strategic, conceptual, and creative thinking, with a strong continuous improvement mindset to enhance processes and outcomes.
- Scientific & Industry Expertise: Brings a solid scientific foundation with experience across multiple therapeutic areas within the pharmaceutical/biotech industry.
- Influence & Communication: Exceptional communication and influencing skills, able to build alignment and lead effectively within a global matrix organization.
SPECIAL NOTE ON BIOGEN ACQUISITION
Please note that as of May 14th, Biogen Inc. has acquired Apellis Pharmaceuticals. Click here to learn more about Benefits & Perks of working at Biogen: Benefits | Biogen
Work Arrangement:
Travel Requirements:
Education:
Benefits and Perks:
Apellis offers a comprehensive benefits package, inclusive flexible time off, summer and winter shutdowns, paid family leave and more!
Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science 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 C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases. 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 LinkedIn and X .
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.
