What you’ll do:
- Support a wide variety of GxP activities to support Adverum’s quality compliance initiatives.
- Provide risk-based quality oversight to vendor qualification activities and ensure compliance with internal procedures and documentation.
- Create and manage vendor audit schedules. Conduct audits and interact with vendors to ensure compliance with internal requirements. Ensure vendor packages are complete and inspection ready.
- Assist with executing internal audits and maintaining the internal audit program and ensure compliance with quality objectives and regulatory requirements.
- Assist with regulatory inspections and oversee the inspection readiness plan. Support inspection readiness activities, as directed by QA management.
- Works closely with other functions to assure consistency and implementation of best practices.
- Foster a quality culture and compliance within the team, promoting teamwork, accountability, and continuous learning.
- Perform other responsibilities as assigned by QA management.
About you:
- Direct auditing experience is required. Certified Quality Auditor certification is preferred.
- Bachelor’s degree in biological sciences or related field; Master’s degree preferred.
- 5-7 years progressive Quality Assurance and GxP compliance experience in pharmaceutical, biologics or advanced therapies;
- Extensive working knowledge and understanding of ICH, US FDA, EU and other relevant regulations.
- Ability to work and communicate effectively in a team environment with great organizational skills that enables risk-based quality management and a culture of quality and open dialogue.
- Possess effective interpersonal, verbal, and listening skills.
- Must be an individual with proven initiative, demonstrated accountability, and ability to manage multiple priorities in a fast-paced environment with high degree of flexibility.
- Ability to travel.
Top Skills
What We Do
Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary, intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
