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

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

Join to apply for the Global STO Quality Head Medical Devices and Combination Products (d/f/m) role at Sandoz Österreich.

Overview

The Global STO Quality Head for Medical Devices and Combination Products (MDCP) defines the MDCP Quality strategy and leads lifecycle management for standalone medical devices and drug-device combinations across Sandoz’s internal and external portfolio. This senior role provides 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 acts as a matrix leader for MDCP quality teams across functions (Sites, ESO), with 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.

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.

Essential Qualifications

• 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 Qualifications

• 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 Kindergarten 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, the minimum salary is EUR 85,704.64/year (full-time). The actual salary will be higher based on experience and qualifications. This salary and benefits package is based on Austrian market standards; for roles filled in other countries, local benchmarks apply.

Why Sandoz?

Generic and biosimilar medicines are the backbone of the global medicines industry. Sandoz is a leader in this sector, serving hundreds of millions of patients worldwide. We invest in development capabilities, production sites, acquisitions, and partnerships to shape the future of affordable, high-quality medicines.

Commitment To Diversity & Inclusion

We are committed to building an inclusive work environment with diverse teams. If you require assistance during the application process due to a medical condition, disability, or neurodiversity, please contact jobs.austria@sandoz.com.

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