Global Head – Sterility Assurance

Kerr Dental

Global Head Sterility Assurance leading sterility assurance and aseptic quality across Novartis manufacturing network and ensuring compliance with cGMP requirements.

Posted 6/5/2026full-timeSchaftenau • 🇩🇪 GermanyLeadWebsite

About the role

Key responsibilities & impact

The Global Head Sterility Assurance provides strategic leadership for sterility assurance and aseptic quality across the Novartis manufacturing network.
This role leads Quality Assurance leaders and Senior Global Aseptic Processing Experts to ensure aseptic operations comply with cGMP requirements, health authority regulations, and Novartis Quality Manual and Policy standards.
The role oversees sterility assurance performance across approximately 20–30 aseptic manufacturing sites, including Large Molecules, Aseptics, Advanced Therapies, and Radioligand Therapy platforms.
It drives alignment, communication, inspection readiness, and sustainable compliance across the network.
Key responsibilities include ensuring readiness for FDA and other health authority inspections, supporting compliance with evolving GMP expectations such as EU GMP Annex 1, tracking remediation actions, and preventing repeat observations.
In partnership with Technical Operations and site Quality teams, the role also supports quality programs, aseptic project metrics, documentation standards, and continuous improvement initiatives.

Requirements

What you’ll need

Graduate degree in Chemistry, Pharmacy, Microbiology, or a related scientific discipline; Ph.D. or advanced degree preferred.
10–15 years of pharmaceutical industry experience, including senior management or leadership roles in Quality Assurance, Quality Operations, Compliance, or global/site quality functions.
Strong experience in pharmaceutical manufacturing, preferably within an FDA-regulated and global cGMP environment.
In-depth knowledge of cGMP requirements across the US and EU, including self-inspections, third-party audits, deviation and complaint management, GMP training, and SOP systems.
Deep technical understanding of microbiology, sterility assurance, and aseptic processing.
Proven people leadership, stakeholder management, negotiation, communication, and escalation skills across diverse global teams and functions.
Strong project management experience, with the ability to lead complex cross-functional and global initiatives.
Fluent English communication skills, both written and spoken.

Benefits

Comp & perks

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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Hard Skills & Tools

cGMPaseptic processingmicrobiologyquality assurancequality operationscomplianceGMP trainingSOP systemsdeviation managementcomplaint management

Soft Skills

people leadershipstakeholder managementnegotiationcommunicationescalation skillsproject managementcross-functional leadershipglobal initiative leadership