Quality and Regulatory Manager needed for German Chemicals Company in Hamburg. The successful candidate will design, implement, and manage QM systems and processes, ensuring compliance with regulatory standards for active pharmaceutical ingredients. This role focuses on achieving and maintaining certifications for ISO 9001, 14001, 5001, and 45001, with GMP/GDP knowledge as a valuable addition.
Key Responsibilities:
- Lead the Quality Management and Quality Assurance department, designing and executing QM systems and processes.
- Oversee the expansion of the QMS, implementing global projects to ensure consistency and compliance.
- Ensure compliance with quality and regulatory standards for active pharmaceutical ingredients.
- Focus on achieving and maintaining certifications for ISO 9001, 14001, 5001, and 45001.
- Utilise GMP/GDP knowledge to enhance quality and regulatory practices.
- Collaborate with global teams to standardise and improve quality processes across multiple locations.
- Provide training and support to teams on QM procedures and best practices.
- Prepare and present detailed reports on QM performance and areas for improvement.
Qualifications:
- Bachelor's degree in Chemistry, Chemical Engineering, or a related field.
- Extensive experience in quality and regulatory management within the chemical or pharmaceutical industry.
- In-depth knowledge of ISO 9001, 14001, 5001, and 45001 standards.
- GMP/GDP knowledge is highly desirable.
- Proven ability to design and implement QM systems and processes.
- Strong leadership skills and experience managing a team.
- Excellent communication and interpersonal skills.
- Proficiency in English and German.
