Senior Quality Assurance Manager , LM ( Biosimilars )

Job Description Summary

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

The position ensures all aspects of manufacturing, testing, release and distribution for key biologics and sterile pharmaceutical products at strategic external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Sandoz Quality Manual, and the applicable Quality Agreements. To lead and guide the team as a people manager.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Acts according to Sandoz values and behaviours. Provides direction and formulates strategies to maintain and improve external supplier quality oversight. Establishes and maintains quality relationship with suppliers.
• Acts as Single Point of Contact / SPOC for all quality related activities at assigned external suppliers. Provides the quality presence and input to technical meetings with the external suppliers and establishes good working relationships. External supplier quality related activities are further described in the subsequent paragraphs. Conducts all necessary trainings in due course to be suitably qualified to perform the assigned duties.
• Supplier qualification: Ensures a valid Quality Agreement in line with the requirements of the Sandoz global template is in place and continuously amended to the business needs. Ensures current external supplier quality risk assessments are in place and appropriate actions are taken to mitigate potential risks. Ensures site readiness for regulatory inspections and quality audits and supports during such events.
• Routine monitoring: Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews. Critically assesses the performance of the product and process performed at the external supplier. Escalate any issues or instances of instability as necessary.
• Incident management: Manages all quality issues (complaints, deviations, OOX). Ensures investigations are correctly executed and all required actions are taken appropriately and in a timely fashion. Escalates and represents cases within the Sandoz quality escalation process and initiate any market action that is required.
• Change controls: Ensures that change requests, either from the external supplier or from Sandoz, are managed appropriately from receipt, through to the implementation and closure. Manufacturing process and analytical methods transfers: Ensures QA Oversight during commercial product transfers. Assesses validation readiness. Ensures knowledge transfer for stable commercial manufacturing operations. Supports the establishment of continuous process verification programs.
• Ensures all aspects of Quality Management of the assigned project are carried out according to the standards defined. Implements and monitors Key Performance Indicators (KPI) and ensures that all parts of ESO are working in a consistent manner against harmonized expectations. Initiates corrective actions when necessary and performs follow-up on resulting measures.
• Ensures that management is kept informed about all critical and major issues which may have an adverse effect on the quality of the product produced at the assigned external suppliers.
•  Number and severity of cGMP issues identified during audits and inspections of External Supply Operations Quality and/or External Supplier. No major or critical observations impacting business continuity, which have not been identified through site quality risk management.
• Overall external supplier performance as reflected in the supplier quality risk assessment. Robustness of risk mitigation (CAPA closure effectiveness, supplier management). Performance towards the achievement of defined Key Quality Initiatives

What you’ll bring to the role:

Essential Requirements:

• Bachelor or higher in Biochemistry, Chemistry, Microbiology or an- other related science
• Around 10  years of Expert knowledge in aseptic/sterile pharmaceutical processes and manufacturing of biologics / biosimilars.
• Handson experience in operational quality assurance. Expert knowledge of cGMP requirements for major regulated markets (EU, US). Advanced experience with FDA, EMEA and other Health Authorities. Expert in risk management. Advanced understanding of project management.
• Expert in communication and advanced negations skills. Advanced decision-making skills. Basic leadership skills.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! 

Join us!

Skills Desired

Agility, Business Acumen, Business Partnering, Collaboration / Teamwork, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gmp Procedures, Goal-Oriented, Health Authorities, Leadership, Logical Thinking, Problem Solving Skill, Problem Solving Skills, Qa (Quality Assurance), Self-Awareness, Smart Risk Taking, Sop (Standard Operating Procedure)  , Technological Expertise