Quality Assurance Manager
hace 4 semanas
About Us
Laboratorio STADA, S.L. is a leading pharmaceutical company that pursues the purpose of "Taking care of people's health as a trusted partner." Our decisions and actions are driven by our purpose, vision, and values. We offer a wide range of therapeutic options to patients, doctors, and pharmacists through our Generics, Consumer Healthcare, and Specialties products.
Our team of around 13,000 employees lives our values of Integrity, Entrepreneurship, Agility, and One STADA, enabling us to achieve our ambitious goals and shape a successful future for our company. We continually expand our goals in line with our ambition and achieve them with passion, commitment, and a growth mindset.
The Role
We are seeking a highly skilled Quality Assurance Manager to support our Quality strategies for the Specialties department. The successful candidate will be responsible for providing oversight activities for quality processes according to current GMP regulations and internal performance metrics for the specialties business.
The ideal candidate will have a university degree in biologics/biosimilars, pharmaceutical sciences, natural sciences, or a related field, with at least 5 years of experience within the pharmaceutical industry as part of a Quality organization. They will also have several years of experience in a related Quality Leader role and several years of experience with a biologics/biosimilar/specialties manufacturing site.
Responsibilities
- Support Quality strategies for the Specialties department in line with Global Quality Policies and Strategic direction for the specialties business.
- Provide oversight activities for quality processes according to current GMP regulations and internal performance metrics for the specialties business.
- Provide oversight of testing and release activities to ensure products are released in time and in compliance with current registered Marketing authorization requirements for the specialties business.
- Monitor and analyze quality performance, support in development of mitigation plans, and assist in the implementation of quality and productivity improvement projects in the Quality organizations of the sites in Specialties department (internal and where applicable, external).
- Provide training and support in the development of the capabilities of Quality employees in the Specialties department.
- Continuously assess the QA and QC performance of the sites in the department, identify areas for improvement, and work with the SQH to implement remediation plans.
- Support to develop, maintain, and continuously improve Quality processes of the Specialties department.
- Continuously support the assessment of the Compliance level of the sites (internal and external) within the Specialties department, identify improvement opportunities, and assist to implement remediation plans as required, for internal sites and where applicable, for external sites.
Requirements
- University degree in biologics/biosimilars, pharmaceutical sciences, natural sciences, or a 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.
We look forward to receiving your application through our job portal. At One STADA Career Portal, you will also find more job opportunities as we are always looking for talent to strengthen our team in line with our growth ambitions.
STADA offers 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.
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