QA Manager, GCP

At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role excites you but you’re unsure if you meet every requirement, we encourage you to apply. Your unique perspective and experiences could be exactly what we need. We look forward to hearing from you! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: Competitive compensation for your work Generous time off policy Opportunity to broaden your horizons by attending popular conferences Emphasis on work/life balance Collaborative and team-oriented environment Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments Due to the hybrid nature of the job, candidates must reside within commuting distance to Raleigh, NC The QA Manager, GCP is responsible for: Ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area Providing quality guidance and support for GCP/GCLP and GPP-related activities within Sobi, including audits, inspections, and risk assessment of BLA/NDA/IND/CTA submissions under the global umbrella. Support the collection of the data needed for Audit program risk assessment Support clinical studies-related activities from a quality perspective across Sobi Ensure qualification of global and local ESP, as applicable, in GCP-regulated areas per Sobi procedures The employee will in this role work with relevant stakeholders across the Sobi organization. Key responsibilities: Ensure GCP audit management excellence of