
Quality Assurance Director
4 days ago
Sobi encourages candidates to apply regardless of their qualifications.
We are a global biopharmaceutical company dedicated to rare diseases. Our work redefines care and transforms lives.
As a diverse team, we strive for growth towards becoming a global leader, prioritizing patients and innovation.
We value an inclusive workplace that fosters growth and development.
The Quality Assurance Director leads the development of a consistent Quality Culture across affiliates.
This role ensures Country Quality Organization and quality systems & processes support Sobi's overall business strategy.
Key Responsibilities:
- Develop and embed a consistent Quality Culture across all affiliates.
- Implement global quality systems, regulatory standards, and governance processes.
- Ensure compliance with GxP regulations and local requirements.
- Collaborate with global and local teams to resolve escalations.
- Prepare for local regulatory inspections and manage follow-ups.
- Drive efficiency, quality improvements, and cost-consciousness.
- Engage with Health Authorities to track commitments effectively.
- Support global initiatives and affiliate onboarding.
A strong and inspiring leader with excellent communication and collaboration skills is required. The ideal candidate has a proactive mindset, coupled with a sense of ownership and accountability.
They excel at solving complex challenges, navigating cultural contexts, and demonstrating empathy and courage in their work.
With a keen business acumen, they engage with stakeholders and manage strategic priorities effectively.
Key Qualifications:
- Master's degree/PhD in Pharmacy, Engineering, Chemistry, or a related field.
- Minimum 15 years of experience in quality, manufacturing, or regulatory affairs in the pharmaceutical industry.
- At least 10 years of leadership experience in international, matrixed organizations.
- Deep understanding of global regulatory and GxP requirements across markets (US, EU, APAC, LATAM, MENA).
- Proven success in performance management, KPI implementation, and lifecycle management.
- Expertise in GVP and GCP, driving business improvements and working with stakeholders.
About Us
We are a global company with over 1,800 employees in more than 30 countries, committed to societies where we operate.
Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here.
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