Global Head (m/f/d), GMP Audit EU I

Novartis Technical Operations
Division Novartis Technical Operations
Geschäftseinheit NTO QUALITY
Standort Holzkirchen (bei München)
Funktionsbereich Qualität
Art der Stelle Vollzeit
Anstellungsverhältnis Unbefristet
StellenID 261607BR


Job purpose:

Manage the audit functions within the EU 1 region. The incumbent will work collaboratively to manage the Novartis Unified Quality Audit Program (UQAP) through effective execution of the audit program focusing on internal, 3rd party manufacturing operations, and external suppliers. Provide governance and oversight of Novartis across business units/functions for the area of responsibility through risk based system assessments of the operations, audits, compliance upgrade projects and inspection management.

Assures remediation activities are undertaken and implemented at all affected sites and divisions, and verifies effectiveness.

Your Responsibilities:

• Direct and manage the audit Associates through a matrix with the other regional heads
• Establish and execute an effective audit program for all internal, external 3rd parties, and suppliers
• Collect and report metrics on the audit activities in accordance with prescribed processes and timelines; manage the business and address any potential signals as necessary to assure effectiveness
• Contribute to timely and successful product launches by assuring pre-approval inspection (PAI) readiness and maintaining an effective PAI audit program
• Act a key contact for GMP audit; must be a GMP SME and effective communicator
• Coordinate audits in the assigned region, and across regions, through a collaborative matrix approach, working collaboratively with the audit planning functions and other regional management


What you’ll bring to the role:

• Graduate degree in Chemistry, Pharmacy, Microbiology, Engineering or another related science; additional knowledge in Quality Assurance and Auditing
• Minimum 12 years of broad experience in the Pharmaceutical Industry or a related regulated industry. Valid operational experience includes quality management, QA operations, production, development or QC operations, or other relevant experience working at a regulatory health authority. Broad business awareness
• Excellent oral and written English communication skills. Second language is desirable
• Profound GMP experience and direct contact with global health authorities within and outside of the inspection environment
• Profound management experience
• Effective negotiation skills, excellent interpersonal and presentation skills. Ability to work with various organizational levels and in a team environment, in multiple roles
• Up to 50% of travelling

Why consider Novartis?
927 million. That’s how many lives our products touched in 2017. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.

Novartis stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

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