QA Manager, GCP

This is a fully remote position, open to applicants in Qatar.

📋 Description

• Overseeing quality assurance and quality by design activities within the GCP/GCLP framework.

• Provide guidance and support from a quality standpoint for GCP/GCLP and GPP activities at Sobi, which includes audits, inspections, and risk assessments for BLA/NDA/IND/CTA submissions under the global umbrella.

• Assist in gathering the data required for the Audit program risk assessment.

• Offer quality support for clinical study activities across Sobi.

• Ensure the qualification of both global and local ESP in the GCP regulated area according to Sobi procedures, as applicable.

• Manage GCP audits with excellence by overseeing the entire audit management process and keeping track of assigned audits as scheduled.

• Evaluate and approve GCP deviations (both global and local, as applicable) and GCP-related CAPAs from a quality perspective.

• Prepare regular status reports on audits conducted, including trends in audits, deviations, CAPAs, and agreed-upon metrics to maintain quality oversight.

• Aid in the GCP audit risk assessment in accordance with SOPs.

• Actively participate in cross-functional teams with procurement and business owners to meet GxP and Quality requirements, ensuring documented qualifications of GCP service providers and reviewing contractual provisions and Quality agreements, as applicable.

• Serve as QA representative during GCP inspections at both global and site levels, contributing to the Inspection Readiness framework and fostering a continuous quality mindset throughout Sobi.

• Author GCP QA-related processes and provide review and guidance under the global framework.

⛳️ Requirements

• A university degree or equivalent in Life Sciences or a related field.

• Minimum of 5 years of experience in the pharmaceutical industry, specifically in Clinical Quality Assurance or the operational execution of clinical trials, alongside GCP audit and/or Quality Assurance experience.

• Comprehensive knowledge of applicable ICH GCP guidelines, industry best practices, and regulatory requirements from FDA, EMA, and ROW.

• Documented education and experience in QA systems, with a preference for auditing experience.

• Organized, results-oriented, and detail-focused.

• Strong interpersonal abilities, coupled with a communicative and adaptable attitude.

• Proactive and collaborative approach.

• Exceptional multi-tasking capabilities with high resilience under stress and strong adaptability skills.

🏝️ Benefits

• Competitive compensation for your contributions.

• Generous time-off policy.

• Opportunities to expand your knowledge by attending popular conferences.

• Strong emphasis on work/life balance.

• A collaborative and team-oriented work environment.