Site Quality Head (m/w/d)

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Overview

Role: Site Quality Head responsible for leading the site Quality Unit, ensuring cGMP compliance, and directing quality initiatives at the site.

Your Responsibilities Include

• Provide leadership, direction and support to the site Quality Unit
• Lead strategic site initiatives and represent site SLT quality in local cross-functional teams
• Assure site inspection readiness and lead Health Authority inspections (e.g., US FDA, EMEA)
• Ensure overall compliance to cGMP during manufacturing, testing and distribution of drug products, meeting Sandoz and Health Authority requirements
• Implement local quality systems that comply with Sandoz standards and international regulations; ensure effectiveness of quality systems
• Drive site management team accountability; coordinate the Site Quality Plan, DI Plan, Site Quality Risk Assessments and other gap assessments
• Foster a culture of continuous improvement and quality excellence; support cross-functional collaboration and talent development
• Oversee budget preparation and consolidation for the Quality Unit
• Manage product critical quality issues; ensure investigations, CAPAs, and CAPA effectiveness follow-up
• Ensure timely notification, escalation and reporting of quality issues/defects
• Strategic planning and control of work processes in the quality unit
• Define, implement, monitor, consolidate and analyze Site Quality KPIs; establish Site Quality Committee and ensure CAPAs are endorsed and implemented
• Oversee occupational safety, health and environmental protection in the area

What You’ll Bring To The Role

• Education in natural sciences or equivalent
• 10+ years of professional experience in the pharmaceutical industry in Quality or Manufacturing (e.g., Site Head, Production Head or Site Quality Head)
• Proven track record in operating in full compliance with global cGMP; experience managing Health Authority inspections (US FDA, EMEA)
• In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211), local and ICH regulations
• Proven ability to manage risk and lead with strategic foresight

You’ll Receive

Sandoz supports personal growth with access to Coursera and other learning platforms (200,000+ videos, 5,000+ courses). Benefits include:

• 30 days of annual leave
• Holiday allowance
• Rewards for special occasions (e.g., service length awards, marriage celebration)
• 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 is a leader in this sector, with momentum driven by open, collaborative culture and flexible-hybrid careers where diversity is welcomed and personal growth is encouraged.

Commitment To Diversity & Inclusion

We are committed to building an inclusive work environment and diverse teams representative of the patients and communities we serve. Hiring decisions are based on qualifications for the position, regardless of gender, ethnicity, religion, sexual orientation, age or disability. For applicants with severe disability, the local representative body can be involved upon request.

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Magdeburg, Saxony-Anhalt, Germany

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