QA Manager, GCP

Job Description The QA Manager, GCP is responsible for: Ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area. Guide and support from a quality perspective the GCP/GCLP and GPP related activities within Sobi, including audits, inspection, and risk assessment of the BLA/NDA/IND/CTA submissions under global umbrella. Support the collection of the data needed for audit program risk assessment. Support quality perspective the clinical studies related activities across Sobi. Ensure qualification of global and local ESP, as applicable, in GCP regulated areas per Sobi procedures. Collaborate with relevant stakeholders across the Sobi organization. Key Responsibilities Ensure GCP audit management excellence of the end‑to‑end audit management process and overview of assigned audits, as planned. Assess and approve from a quality perspective the GCP deviations (global and local, as applicable) and GCP related CAPAs. Prepare regular status reports on performed audits, audit trending, deviation trending, CAPA trending and agreed metrics to ensure quality oversight. Contribute and support the GCP audit risk assessment according to SOPs. Ensure active contribution in the cross‑functional team with procurement, business owners for GxP and quality requirements, and documented qualification of GCP service providers; review provisions in contracts/quality agreements, as applicable. Act as QA representative during GCP inspections at global and site levels, contributing to the Inspection Readiness framework and promoting a continuous quality mindset across Sobi. Author GCP QA related processes, review, and provide guidance under the global umbrella. Qualifications University degree or equivalent in Life Sciences or a related discipline. At least 5 years of experience in the pharmaceutical industry in Clinical Quality Assurance or in the operational conduct of clinical trials, including GCP audit and/or Quality Assurance experience. Excellent knowledge of applicable ICH GCP guidelines, industry best practices, and FDA, EMA and other regulatory requirements. Understanding of quality assurance activities principles and know‑how. Documented education/experience in QA systems and preferably auditing. Structured with focus on results and detail oriented. Strong interpersonal skills with a communicative and flexible attitude. Proactive and collaborative mindset. Strong multitasking abilities with high resilience to stress and adaptive skills. Compensation and Total Rewards Base salary range for this role is $112,000 – $153,000. The final offer will be determined based on experience, qualifications, and location. Short‑term and long‑term bonuses are also eligible. Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements, and individual qualifications without regard to race, color, religion or belief, national, social or ethnic origin, sex, age, disability, or any other status protected by applicable law. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access the application process. Learn more about our accommodations policy. #J-18808-Ljbffr Swedish Orphan Biovitrum AB (publ)