Sr. Manager Compliance

hace 4 días


Barcelona, España Stada Arzneimittel Ag A tiempo completo

.Select how often (in days) to receive an alert:ABOUT USAt STADA we pursue the purpose of "Taking care of people's health as a trusted partner." All our decisions and actions are driven by our purpose, vision and values. With our wide range of products: Generics, Consumer Healthcare and Specialties, we offer patients, doctors and pharmacists a wide range of therapeutic options.Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA, in order to achieve our ambitious goals and shape a successful futurefor our company. We continually expand our goals in line with our ambition, and we achieve them with passion, commitment and a growth mindset.Do you want to be part of a successful international pharmaceutical company and grow with us?The Sr. Manager Compliance & Excellence, Global Quality Specialties:RESPONSIBILITIES*Is responsible for supporting Quality strategies for the Specialties department in line with Global Quality Policies and Strategic direction for the specialties business.*Is responsible to provide oversight activities for quality processes according to current GMP regulations and in line with internal performance metrics for the specialties business*Is responsible to provide oversight of testing and release activities to ensure products are released in time and in compliance with current registered Marketing authorization requirementsfor the specialties business*Monitors and analyzes quality performance, supports in development of mitigation plans, and assists in the implementation of quality and productivity improvement projectsin the Quality organizations of the sites in Specialties department (internal and where applicable, external).*Provides training and supports in the development of the capabilities of Quality employees in the Specialties department.*Continuously assesses the QA and QC performance of the sites in the department, identifies areas for improvement and works with the SQH to implement remediation plans*Supports to develop, maintain and continuously improve Quality processes of the Specialties department*Continuously supports the assessment of the Compliance level of the sites (internal and external) within the Specialties department, identifies improvement opportunities andassists to implement remediation plans as required, for internal sites and where applicable, for external sites.QUALIFICATIONS*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)We look forward to receiving your application through our job portal


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