Head Sandoz Compliance in Holzkirchen

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz!

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Ensure and lead Global Quality Compliance activities for SDZ including development, sites, countries, business units & provide strategic guidance to local QA Compliance teams
• Ensure site readiness for Regulatory Health Authority Inspections through normal audit activities, "Mock Inspections", training and other support activities. Prepare entities for major Health Authority Inspections (e.g. FDA, EU, ANVISA).
• Supervise, manage, support that quality problems across the company are resolved consistently with international & global cGMP standards
• Lead, participate, support and supervise global quality/ compliance initiatives and cGMP upgrade projects in line with business objectives
• Assure that all product quality emergency situations are managed and closed in a GMP compliant way and communicated accordingly as well as effective corrective and preventive actions established
• Build the right compliance team with the needed skills and capabilities for Sandoz following Sandoz key strategic targets
• Set priority compliance remediation projects based on internal QMS monitoring signals and new regulatory requirements

What you’ll bring to the role:

Essential Requirements:

• FDA & other International Authorities practical experiences in different Technical functions including local and global Quality
• Excellent technical knowledge on GMP legislation specifically US FDA and EU
• Excellent communication and organizational skills within Quality organization and with other stakeholders
• Excellent skills in identifying issues and solve problems - Solution oriented
• High Level of resilience

Sandoz has an employee-first approach and that’s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.

In addition to the various learning opportunities, we offer company benefits, such as:

• 30 days of annual leave
• Holiday allowance
• Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
• Company pension schemes and capital formation benefits
• Parental leave
• Other offerings, such as bike leasing

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:

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

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Sandoz Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities, join the Sandoz Network here: https://talentnetwork.novartis.com/sandoztalentpool

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