Head Development QA Drug Delivery Systems

Job Description Summary

Job Description

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 Head Development QA Drug Delivery Systems is a permanent member of the SGD Quality Leadership Team and is accountable for the oversight of Quality activities associated with technical development of drug delivery systems including Medical Devices until commercialization. Quality advice will be provided to the Sandoz Device Development Centre but also to other functions involved in device development. Responsible for setting direction with respective functions to ensure compliant commercialization and maintenance of Drug Delivery Systems including Medical Devices. Collaborating with the Quality System Owner(s) to continuously improve and update the respective Quality Management System.

Your Key Responsibilities:

Your responsibilities include but not limited to:

• The Head DevQA Drug Delivery Systems is responsible for the deployment and execution of the Quality and Compliance strategy incl. tools related to Drug Delivery Systems regulations to ensure uninterrupted development and subsequent supply of products.

• Provides Quality governance in compliance with national and international GxP device regulations and internal design control standards as well with applicable quality requirements.

• Acts as a consultant for Life Cycle Management activities for already commercialized combination products. Therefore is part of the respective network and cross-functional Medical Device Boards to ensure alignment in the implementation of the Medical Device Quality strategy for Sandoz E2E.

• Owns and manages together with the DevQA team quality related problems/ matters for the assigned Drug Delivery System product portfolio to ensure they are resolved consistently and in accordance with Sandoz standards and policies.

• Supports inspections and audits at development sites and supports regulatory inspections of manufacturing sites involved in Drug Delivery System manufacturing testing and assembly as needed.

• Accountable for the escalation of Quality & Compliance issues associated with Drug Delivery Systems to Management in accordance with Sandoz requirements and supports the implementation of remediation actions in a timely and robust manner.

• Responsible for product assessments Medical Device Reporting and recall activities per the Sandoz standards and policies. Manages communication and interfaces with external contacts were appropriate: Industry and Health Authorities. External interaction with national and international regulatory bodies (e.g. European Medicines Agency (EMA) Food and Drug Administration (FDA) and Notified Bodies (NBs) mainly require interpretation of complex information; internal interactions require negotiation with and persuasion of function leadership and site management teams.

• Participates in external working groups or standard setting organizations to influence regulatory and/or technical requirement definition affecting Drug Delivery Systems.

• Leads actively engages in and supports Quality programs as needed.

• Supports and ensures compliance for due diligence and integration projects for Drug Delivery Systems.

• Collaborates to ensures GxP compliance of Drug Delivery Systems of alliance projects.

• Identifies resource and skill gaps subsequently- Recruits staff as required and Supports the team members in their personal development and in determining training needs

• Strives to consistently uphold Sandozs core values

What youll bring to the role:

Essential Requirements:

Youll receive:

Competitive salary Annual bonus Pension scheme Health insurance 24 days annual leave Flexible working arrangements Employee recognition scheme learning and development opportunities.

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!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

Skills Desired