Quality Specialist (m/f)

REFERENZNUMMER:

366427/11

IHRE AUFGABEN:

-Support establishment of GxP policies, SOP and supporting documents throughout all of the Roche development related organizational enterprises (gRED, pRED, PD, GPS and affiliates) to ensure a consistent GxP process landscape for standards and processes and procedures related to clinical development and safety/pharmacovigilance which meet internal and external standards of regulatory compliance, as well as industry best practices and interpretations
-Build and maintain strong relationships with key business stakeholders and ensure that PDQ is providing an efficient, effective and compliant process landscape to the functions
-In close collaboration with supported functional areas and key business stakeholders, identifies needs for process standardization, regulatory compliance direction and areas for improvement
-Ensure that business partner expectations for SOP strategy, materials and deployment are met
-Ensure, in collaboration with business partners, that policies and SOPs in the GxP process landscape are up-to-date and regulatory compliant versus current clinical and safety/pharmacovigilance international regulations
-Collaborate with a network of subject matter experts (SMEs) across the functional areas, supporting policy, SOP and supporting document development
-Contributes to the PDQ QS standards, systems & processes governance team to set strategies and achieve the long-term goals and objectives of PDQ QS and PDQ as a whole
-Knowledgeable of all services and activities provided by PDQ QS, standards, systems and processes governance in order to provide business stakeholders with a comprehensive overview and effectively communicate this to stakeholders
-Support internal process improvement projects

IHRE QUALIFIKATIONEN:

-Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training, and experience
-Good knowledge in the pharmaceutical industry, preferably in pharmaceutical development and working in a GxP regulated area
-Experience in preparation, development and administration of GxP standards and processes
-Organizational awareness (e.g. interrelationship of departments, business priorities), including experience in successfully working cross-functionally and in global teams

WEITERE QUALIFIKATIONEN:

Quality manager