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.
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.