FAQs
What are the key responsibilities of the Associate Director ESP Quality role?
The key responsibilities include reviewing and approving External Service Provider qualifications, negotiating Quality Assurance Agreements, conducting Quality Risk Assessments, managing quality issues, collaborating with business partners, ensuring inspection readiness, and ensuring compliance with regulatory requirements.
What qualifications are required for this position?
A minimum of a bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related discipline is required.
How many years of experience are preferred for this role?
A minimum of 12 years’ experience in pharmaceutical development and knowledge of quality management systems, clinical operations, and vendor management activities is preferred.
What languages are required for this position?
Fluent English (both spoken and written) is required.
Is experience in managing External Service Providers necessary?
Yes, experience in managing External Service Providers and knowledge of applicable quality standards and regulatory requirements is important.
What types of audits and inspections will the Associate Director support?
The Associate Director will support internal and external audits, as well as health authority inspections pertaining to External Service Provider management.
What kind of skills are sought after for the ideal candidate?
Candidates should have knowledge of GCP/GLP, GMP, GVP, experience in data analysis, root cause analysis skills, stakeholder engagement, and demonstrated leadership in implementing robust quality processes.
In which locations is this position available?
The position is available in Munich and Nuremberg, Germany.
What type of employment is offered for this role?
The position is a full-time regular employment opportunity with no shift work required.
Does Novartis provide opportunities for career development?
Yes, Novartis encourages career development and offers resources to help employees thrive both personally and professionally.