QA Senior Manager Biosimilars

Sandoz

Ljubljana, Slovenia

As QA Senior Manager Biosimilars you will be responsible for the development and verification of the internal quality system compliance to mitigate risks related to product/API quality and to reduce costs associated to poor product quality, pursuant to the law, internal regulations, good practices and business objectives.

Your key responsibilities:

Your responsibilities include, but not limited to:

Responsible for the development of an internal quality system for Biosimilar Development projects and ensuring Quality compliance as per pharmaceutical regulations, good pharmaceutical practice and Sandoz requirements e.g. internal procedures and as defined in Quality Assurance Agreements with external partners (QAAs).
Review of documentation and responsibility for giving quality guidance based on regulations and standards but give room for scientific and technical discussions.
Responsible for the conduct of internal and external audits of the quality system (approval of suppliers, contract suppliers and contract manufacture suppliers).
Negotiation of Quality Assurance Agreements (QAA) with external partners.
Change and deviation management, complaint handling.
Escalate risks and issues, as well as propose mitigating actions.
Responsibility for ensuring timely achievement of project Quality deliverables.
Contribute to process simplification and QMS improvements.

What you will bring to the role:

University degree in Microbiology, Biotechnology, Biochemistry or equivalent.
Minimum 5 years of working experience in Biopharma quality/quality assurance or operations (i.e. Upstream/Downstream process development, Drug product development, analytics).
Excellent communication and organizational skills.
Excellent skills in identifying issues and solving problems.
Excellent & detailed knowledge of GMP-regulations.
Fluent in English.
Knowledge of Microsoft Office.

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