Global Quality Compliance Manager (d/f/m)

Job Description Summary

The future is ours to shape.

Job Description

We are looking for the Global Quality Compliance Manager who will manage Global Sandoz Compliance related activities to ensure that all aspects of the operational business in the manufacturing Sites within Sandoz Technical Operations comply with cGxP, legal and regulatory requirements, Sandoz Quality Manual and internal standards.

You will also be responsible to manage knowledge with current industry trends, Health Authority exceptions and influence standards and incorporate them into business process.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Drive GxP Compliance and oversight in Sandoz TechOps and local Manufacturing Sites and expert networks
• Ensure and lead Compliance activities for Sandoz TechOps, provide strategic guidance to local Site QA Compliance teams and Site Quality Heads. Ensure compliance with global standards and policies via active working relationship with Sandoz QMS. Ensure that Sites are implementing GxP compliant processes in line with Sandoz Quality Manual and applicable Health Authority Regulations.
• Lead/contribute global quality/ compliance initiatives and GxP upgrade projects in Sandoz in line with business objectives. Ensure improvement of Sandoz compliance practices, introduce best international compliance practice for generic industry in Sandoz TechOps and support the permanent Sandoz growth with appropriate compliance level of Sandoz operations
• Provide oversight and governance through effective metrics (KQI, KPIs) in alignment with Global Quality reporting strategy. Monitor and report compliance trends and issues. Ensure effective remediation of significant quality and compliance issues.
• Develop and implement the strategies, processes and plans for the inspection readiness and response planning, in line with the policies established by Sandoz Quality Compliance and Auditing. Ensure site readiness for regulatory Health Authority inspections, GCA-inspections and Mock-PAIs
• Supervise/manage/support operations on quality problems and technical matters to be resolved consistently with international & global cGMP-standards. Support Sandoz Quality management in close collaboration with Incident Management, ensure timely and compliant decisions and effective mitigation plans
• Governance process: Lead the Sandoz Quality Governance Board. Ensure effective communication process to share lessons learned related to quality compliance risks and best practices

What you will bring to the role:

• 5 - 10 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, clinical development or manufacturing or a directly related area.
• University degree in natural sciences
• Excellent management, interpersonal communication, negotiation and problem solving skills. Experience in working in a matrix environment
• Project management skills
• Fluent in spoken and writen English
• Proficiency in Microsoft Office tools

You’ll receive:

Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities. 

Possible job locations: Ljubljana, Barcelona, Madrid or Kundl.

We offer a permanent employment, with a 6-month probation period.

You are kindly invited to submit your application in the English and/or Slovene language, including your CV by the 23rd of March 2025.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last 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 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 encouraged!

The future is ours to shape!

Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. 

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: https://talentnetwork.novartis.com/sandoztalentpool

#Sandoz

Skills Desired