Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!

The Global STO Quality Head for Medical Devices and Combination Products (d/f/m) defines the MDCP Quality strategy and leads lifecycle management for standalone medical devices and drug-device combinations across Sandoz’s internal and external commercial portfolio.

This senior role ensures quality oversight and governance of MDCP manufacturing and distribution, aligning with global regulatory standards and clinical/commercial needs.

Reporting directly to the Quality Head for Large Molecules & Injectables (LM&I), the role is part of the LM&I Quality leadership team and serves as the global Quality representative on decision boards. It also acts as a matrix leader for MDCP quality teams across functions (Sites, ESO), with strong collaboration across development, regulatory affairs, MS&T, and suppliers.

This role can be based in Kundl, Austria or at other EU locations (SLO, CH, DE, PL etc.) or the UK.

Your Key Responsibilities:

• Lead the global MDCP Quality strategy across the lifecycle of devices such as auto-injectors, pens, and inhalers.
• Ensure global regulatory requirements (e.g., EU MDR, 21 CFR 820) are embedded in the Sandoz Quality Management System.
• Drive continuous improvement in device quality systems, including complaint handling and risk reduction.
• Oversee site certification efforts and ensure regulatory compliance.
• Monitor product performance and collaborate with Pharmacovigilance to enhance patient experience.
• Provide quality oversight for design history files, supplier management, and tech transfers.
• Build and lead a global MDCP quality network with strong governance.
• Partner with Regulatory Affairs to support global submissions and regulatory strategies.
• Ensure seamless quality integration from development to commercial manufacturing.
• Develop device-specific training programs for relevant sites.
• Collaborate with Clinical, Commercial, and Medical Affairs to integrate user feedback into product design.
• Set and oversee quality standards for CMOs and suppliers.
• Manage budgets, resources, and talent development for the function.

Key Performance Indicators:

• Quality System Effectiveness & Compliance: Ensure high inspection readiness, timely deviation/CAPA closure, and strong QMS maturity (e.g., ISO 13485, MDSAP), with a focus on minimizing human error and improving complaint handling.
• Manufacturing & Supplier Oversight: Maintain supplier audit compliance, reduce lot rejections, and meet quality milestones for new sites and internal production.
• Post-Market Surveillance: Drive proactive complaint trending, timely investigation closure, and high customer satisfaction with quality issue resolution.

What you’ll bring to the role:

Essential Requirements:

• Degree in Engineering, Pharmacy, Quality, or Life Sciences.
• 10+ years of experience in quality management within pharmaceutical/biotech industry, ideally in the medical device and/or combination product sectors,
• Proven track record leading global teams and working in a matrixed environment.
• Deep knowledge of global regulatory requirements governing medical device and combination product quality management (e.g. FDA 21 CFR Part 820, EU MDR, ISO 13485, MDSAP).
• Hands-on experience with lifecycle quality processes such as product release, change control, post-market surveillance, field action management, complaints investigation and management review.
• Experience supporting facility build-outs and validation or tech transfer of device manufacturing processes is highly desirable.
• Language: English (fluent)

Desirable Requirements:

• Executive presence with the ability to influence senior stakeholders and cross-functional partners.
• Strong decision-making, negotiation, and communication skills.
• Familiarity with both generic and biosimilar drug development and commercialization.
• Experience in parenteral and respiratory delivery systems, including injectors, inhalers, or wearable devices.

You´ll receive:

• Attractive salary with incentive program
• Modern company pension scheme
• Flexible working hours / home-office depending on the position
• 14 weeks of paid parental leave
• Additional days off (bridge-days)
• Subsidized meals in our canteen
• Sustainable mobility in the form of company transportation, shift buses and car sharing
• Company Kindergarden and summer camps for children
• Wellbeing & mental health offers
• Learning and development options for your personal and professional growth
• Worldwide career opportunities

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 85.704,64/year (on a full-time basis).

The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

This salary and benefits package is based on Austrian market standards. If the role is filled in another country, local market benchmarks and compensation practices will apply.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art 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 and entrepreneurial spirit are 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 encouraged!

Are you ready to join us? Then we look forward to your application!

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.

If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at jobs.austria@sandoz.com.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talent Pool

Global STO Quality Head Medical Devices and Combination Products (d/f/m)