Sr. Manager Compliance
hace 7 meses
ABOUT US
At 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 future
for 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 requirements
for the specialties business
*Monitors and analyzes quality performance, supports in development of mitigation plans, and assists in the implementation of quality and productivity improvement projects
in 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 and
assists 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)
*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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