Senior Quality Assurance Strategist
Vor 2 Tagen
**Job Title:** Senior Quality Assurance Strategist
**Location:** Germany (remote)
We are seeking a highly experienced Senior Quality Assurance Strategist to lead the development and implementation of our international quality strategy across two key European sites.
**About Us:**
Our client is a clinical-stage Radiopharmaceutical organisation specialising in the development of treatment for solid-tumour state cancers. This is a unique opportunity to join a pioneering team and drive their quality assurance strategy forward.
**Job Description:**
- Develop, implement, and maintain a comprehensive quality assurance strategy for all products at pre-clinical and clinical stage, ensuring compliance with local and international regulatory requirements (EMA, FDA, etc.).
- Oversee the preparation and submission of regulatory filings and inspection readiness for clinical trials.
- Collaborate with cross-functional teams, including R&D, production, and regulatory affairs, to ensure seamless integration of quality systems throughout the product lifecycle.
- Ensure robust risk management practices are in place and lead investigations into deviations, complaints, and corrective actions.
- Monitor and evaluate suppliers, contract manufacturers, and external partners to ensure they meet high quality standards.
- Provide leadership during regulatory audits and inspections, ensuring all findings are addressed in a timely and efficient manner.
**Role Requirements:**
- Educated to Masters level (minimum) in a business or scientific discipline.
- 10+ years' experience in Quality Assurance with a proven track record in clinical-stage radiopharmaceuticals or oncology being highly desirable.
- Strong knowledge of international regulations and frameworks - GLP, GMP, ICH, FDA, ISO 19001 etc.
- Ability to work in a fast-paced, innovative environment with a hands-on approach to problem-solving.
- Fluent in English with German proficiency advantageous.
**What We Offer:**
- Estimated Salary: €120,000 - €150,000 per annum.
- Competitive salary and performance-based bonuses.
- Comprehensive benefits package.
- A collaborative and innovative work environment.
- Professional development and growth opportunities.
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