QA Manager, ESO Biosimilars

QA Manager, ESO Biosimilars

Sandoz

Kundl, Austria

As QA Manager ESO Biosimilars, you will be responsible for managing quality aspects at external suppliers to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Sandoz Quality Manual and is conducted according to the relevant Standard Operating Procedures.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Acts as Single Point of Contact/SPOC for all quality related activities at the External Supplier and establishing good working relationships with clear communication and defined actions and goals.
• 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
• Responsible for the conduct of internal and external audits of the quality system (approval of suppliers, contract suppliers and contract manufacture suppliers).
• Stability reports and PQR’s review and approval.
• Support Quality activities within transfers, launches and deals.
• Participate quality activities within global projects.

What you’ll bring to the role:

Essential Requirements:

• University degree in Microbiology, Biotechnology, Biochemistry or equivalent.
• Working experience in Pharmaceutical industry with direct experience in QA operations.
• Excellent communication and organizational skills.
• Excellent skills in identifying issues and solving problems.
• Excellent & detailed knowledge of GMP-regulations (EMA; FDA, CA, etc).
• Collaborating across boundaries.
• Project Management experience.
• Fluent in English.

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