Quality Assurance Manager
hace 2 meses
About Laboratorio STADA, S.L.
We are a leading international pharmaceutical company dedicated to delivering high-quality products and services to patients, doctors, and pharmacists. Our purpose is to take care of people's health as a trusted partner, and we strive to achieve this through our values of Integrity, Entrepreneurship, Agility, and One STADA.
Job Summary
We are seeking a highly skilled and experienced Quality Assurance Manager to join our team in the Specialties department. As a key member of our Quality organization, you will be responsible for supporting Quality strategies, providing oversight of quality processes, and ensuring compliance with current GMP regulations and internal performance metrics.
Key Responsibilities
- Support Quality strategies for the Specialties department in line with Global Quality Policies and Strategic direction.
- Provide oversight of quality processes according to current GMP regulations and internal performance metrics.
- Ensure products are released in time and in compliance with current registered Marketing authorization requirements.
- Monitor and analyze quality performance, support development of mitigation plans, and assist in implementation of quality and productivity improvement projects.
- Provide training and support in development of capabilities of Quality employees in the Specialties department.
- Continuously assess QA and QC performance of sites in the department, identify areas for improvement, and work with SQH to implement remediation plans.
- Support development, maintenance, and continuous improvement of Quality processes of the Specialties department.
- Continuously support assessment of Compliance level of sites (internal and external) within the Specialties department, identify improvement opportunities, and assist to implement remediation plans as required.
Requirements
- University degree in biologics/biosimilars, pharmaceutical sciences, natural sciences, or related field.
- At least 5 years of experience within the pharmaceutical industry as part of a Quality organization.
- Several years of experience in a related Quality Leader role.
- Several years of experience with a biologics/biosimilar/specialties manufacturing site.
- Fluent in English (written and oral).
- Excellent communication skills.
- Additional training in Change management, Project Management, 6-Sigma, Lean Processes desirable.
About Us
We offer a competitive environment for personal and professional development in a growing company full of opportunities. Our future project requires dynamic and proactive professionals, capable of adding value in a changing environment. We look forward to receiving your application through our job portal.
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