Head ESO Quality Large Molecules and Injectables (dfm)

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!

As the Head ESO Quality Large Molecules and Injectables you will take on a global role accountable to lead and supervise the Quality Units of all FDF and API Supplier Relationship Teams (SRTs) within Sandoz ESO Large Molecules and Injectables. You will ensure all SRTs are operating in compliance to international cGMP standards Sandoz internal rules and applicable regulatory compliance requirements.

This role is fully accountable for the Quality Performance and Results of the assigned ESO Large Molecules organization and has the full responsibility for the budget and headcounts of the respective Quality organization. This role manages the performance of all SRTs and Release Hubs Quality Site Head. You will also ensure that all aspects of the operational business within the respective area of responsibility comply with cGMP legal and regulatory requirements as well as the Sandoz Group Quality Manual and Policies.

Major accountabilities:

Responsibilities include but not limited to:

• Lead a team of QA Leads in various locations around the globe within ESO Large Molecules.

• Ensure the definition of clear targets and objectives for all team members.

• Define ESO release strategy for Large Molecules and Injectables.

• Ensure Quality Units meet global standards/principles with regards to organization personnel qualification training procedures processes performance productivity.

• Drive and support people development and talent management initiatives across the SRTs Hubs and the regions ensuring proper development for QA associates in the assigned roles and adequate implementation of OTR and talent programs.

• Lead and drive oversight and supervision ESO QA related activities within ESO Sandoz LM&I.

• Ensure that a quality management system is in place including proper escalation resolution and decision making in case of compliance issues according to company requirements.

• Ensure Quality issues and risks in the assigned third parties are adequately managed escalated resolved and follow up measures are implemented.

• Support on continuous inspection readiness and timely implementation of CAPA plans supporting/supervising the communication to Health Authorities linked to products manufactured by CMOs and supplied to Sandoz.

• Manage the resolution of GMP issues and significant deviations and investigations. Ensure senior management is notified of significant GMP events through the escalation process and participating in product recall activities as required.

• Take a leadership role in the selection maintenance and termination of Third party manufacturers.

• Ensure that quality and compliance related risks are an integral part of all kinds of business decisions.

• Manage support and supervise selected quality and transformation projects and ensure that quality problems and technical matters are resolved consistently with global standards.

• Review of KQIs internal SRTS and KPIs of external suppliers / contract manufacturers in order to monitor performance and initiate remediation projects in case required.

• Support direct reports in their leadership development and talent management to continuously strengthen the organization and ensure adequately staffed teams with qualified personnel.

• Management of all external QC activities with a specific focus on EU retesting labs in a cGMP compliant and cost-effective manner.

• Ensures products manufactured at third parties comply with cGMP requirements and drive continuous improvements during manufacturing analysis and distribution throughout shelf life.

• Develop and execute a dedicated ESO Large Molecules quality plan in order to drive continuous improvement and corrective measures to enhance quality oversight.

• Ensure and provide guidance on Data Integrity and eCompliance.

• Drive continuous improvement and build operational efficiency by applying SBS principles ensuring 100% engagement and zero losses.

Minimum Requirements:

What youll bring to the role:

• Bachelors degree in Natural Sciences (Chemistry Pharmacy Biotechnology Biology).

• 10 years of experience in the pharmaceutical industry in Quality Operations (e.g. Quality Control Microbiology QA Operations) or Manufacturing (e.g. Site Head Production Head > 100 FTE) or in Site Quality Head roles.

• Thorough knowledge of cGMP requirements a proven track record with FDA EMEA and other Health Authorities and strong knowledge of the pharma market customers and competition.

• Strong leadership capabilities with crosscountry and multicultural experience and a solid understanding of risk assessment and risk management fundamentals/tools.

• Excellent GMP and QA/QC knowledge experience with Health Authority inspections leadership skills financial and OPEX understanding and strong intercultural communication skills.

• Fluent English both written and spoken.

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.

Accessibility and accommodation

Sandoz is committed to working with and providing reasonable accommodation to all individuals. If because of a medical condition or disability you need a reasonable accommodation for any part of the recruitment process please send an e-mail toand let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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Skills Desired