Manager / Senior Manager, GMP Quality Assurance

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.

Position Summary :

Working in a virtual pharmaceutical company, the Pharmaceutical GMP QA Manager will ensure compliance with Health Authority regulations and industry standards. Responsible for managing the GXP vendor audit and oversight program including planning and performing, as needed, external and internal GMP / GLP audits and gap assessments. Directly providing GXP Quality project management support across functional areas. Managing deviations, CAPA resolution and GMP Change Control in the eQMS. Developing GMP. Directly supporting QA disposition and oversight over clinical and commercial drug substances and products, including packaging and labeling. procedures for commercial manufacturing and distribution. Preparing for and supporting Health Authority inspections.

Primary Responsibilities :

• Ensure compliance with FDA regulations and other relevant industry standards for clinical and commercial drug substance and IMP / Drug products
• Manage the GXP (GMP / GLP / GCP / GVP / GDP) vendor qualification and audit program, performing QA oversight and monitoring of GMP vendors including drafting of Quality Technical Agreements, when needed
• Support internal and external GMP audits and Health Authority inspections (US FDA, for example)
• Provide project management support for GXP Quality functions and processes
• Develop procedures and processes for commercial manufacturing and distribution
• Support the development and authoring of GMP Governing Documents (Policies, SOPs, Templates, Forms, Protocols, etc.)
• Support Deviations, CAPA resolution, and Change Control management in a Virtual Company setting
• Support review of CMO batch records, CoAs, and CoCs to disposition clinical and commercial API and IMP / Drug Product
• Lead product investigations and resolution in partnership with the CMC group and with CMOs
• Manage upload and approval of GXP documents to the electronic quality management system (eQMS)
• Support packaging, labeling and distribution of clinical and commercial product
• Support other related responsibilities on projects, as assigned

Leadership and Strategy :

Skills and Qualifications :

Skills and Key Success Factors :

Other Relevant Information :

Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees.