QA Manager, GCP
About The Position
The QA Manager, GCP is responsible for ensuring quality oversight and quality assurance and quality by design activities related to GCP/GCLP area. This role provides 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. The position also supports the collection of data needed for Audit program risk assessment and clinical studies-related activities from a quality perspective across Sobi. The QA Manager ensures the qualification of global and local ESP, as applicable, in GCP-regulated areas per Sobi procedures. The employee will work with relevant stakeholders across the Sobi organization.
Requirements
- University degree or similar in Life Sciences or related discipline
- 5+ years of pharmaceutical industry experience in Clinical Quality Assurance or in the operational conduct of clinical trials and the application of GCP audit and/or Quality Assurance experience.
- Excellent knowhow of the applicable ICH GCP guidelines, industry best practices and FDA, EMA and ROW regulatory requirements.
- 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 communicative and flexible attitude
- Proactive and collaborative mindset
- Strong multi-tasking abilities with high resilience at stress and adaptive skills
Responsibilities
- Ensure GCP audit management excellence of the end-to-end audit management process and overview of the assigned audits, as planned.
- Assess and approve from a quality perspective the GCP deviations (global and local, as applicable), GCP related CAPAs.
- Prepare regular status reports on performed audits, audit trending, deviation trending, CAPAs trending, and agreed-upon 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 and review provisions in contracts/Quality agreements, as applicable.
- Act as QA representative during GCP inspections global and site level, as applicable and contribute to the Inspection Readiness framework and promote a continuously quality mindset across Sobi.
- Authoring GCP QA related processes, review and give guidance under the global umbrella.
Benefits
- 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
- Eligible for both short-term and long-term bonuses
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What This Job Offers
Job Type
Full-time
Career Level
Manager
