Biopharmaceutical Quality Assurance Leadership Role
hace 1 día
About the Company: Almirall Hermal GmbH is a leading biopharmaceutical company dedicated to delivering innovative products and solutions to improve patient outcomes.
Estimated Salary: €120,000 - €180,000 per annum, depending on experience and qualifications.
Job Description:
Senior Manager Biological Products QaWe are seeking an experienced Senior Manager to lead our biological products quality assurance team. The ideal candidate will have a strong background in quality management, excellent leadership skills, and a proven track record of driving quality initiatives across complex projects.
Responsibilities:
- Lead the development and implementation of a robust Quality Management System (QMS) for biopharmaceutical products.
- Oversee key quality systems and deliverables associated with drug development, ensuring compliance with regulatory requirements.
- Drive cross-functional projects and quality initiatives within CMC teams, providing expert quality assurance input.
- Conduct comprehensive risk assessments and communicate quality risks within the quality organization.
- Facilitate the resolution of quality issues on deviations, investigations, CAPAs, and complaints.
- Manage change control throughout the drug development process, ensuring smooth transitions and continuous improvement.
- Lead internal quality audits, supplier audits, process/product improvement projects, supplier evaluation surveys, and disposition activities.
Requirements:
- Minimum 8 years' quality-related experience in the pharmaceutical or biopharmaceutical industry.
- Strong knowledge of GMP and regulatory requirements, including EU, FDA, and ICH.
- Technical working proficiency in quality systems and devices for biologics.
- Excellent organizational, analytical, and problem-solving skills, with a focus on timelines and objectives.
- Ability to influence and collaborate with others, with good written and verbal communication skills in English.
What We Offer:
- A competitive salary and benefits package.
- Ongoing professional development and training opportunities.
- A dynamic and supportive work environment.
About You: As a seasoned quality assurance professional, you possess a deep understanding of quality management principles and regulatory requirements. Your excellent leadership skills, combined with your technical expertise, make you an ideal candidate for this role. If you are passionate about delivering high-quality products and services, we encourage you to apply.
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