Global Gmp Senior Quality Assurance Expert
hace 3 semanas
Role Overview
We are seeking a highly experienced Global GMP Senior Quality Assurance Expert to join our team at Novartis. This is an exceptional opportunity to be part of our Global Auditing function, building upon and maintaining our exceptional standards.
This role comes with a flexible location and we are ready to hire the successful candidate in their preferred city within Spain. As a key member of our team, you will lead, support, and report independent GMP audits according to the Novartis Quality System and current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.
The Global GMP Senior Quality Assurance Expert will ensure alignment with the company's strategic direction and drive implementation of applicable actions. They will also provide consultation to Novartis business units through risk-based assessments and act as a Subject Matter Expert (SME) for assigned areas of responsibility.
About the Role
In this role, you will be required to travel up to 60% of the time. Your major accountabilities will include:
- Supporting the strategic development of an effective global risk-based audit strategy and program.
- Collecting, collating, and incorporating input into the audit strategy and plan.
- Planning, leading, conducting, documenting, and following up on GMP audits according to Novartis Quality procedures and applicable regulations, standards, quality agreements, and guidance documents.
- Providing technical guidance, mentoring, and training on audit activities.
- Preparing audit reports according to NVS requirements and timelines.
- Identifying and reporting best practices and lessons learned to support development/training of GMP auditors.
- Mentoring junior GMP staff as required.
- Acting as a GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed.
The ideal candidate will have at least 12 years of broad experience in the Pharmaceutical or Medical Device Industry.
Requirements
To be successful in this role, you will need:
- A strong understanding of GMP regulations and industry standards.
- Excellent communication and interpersonal skills.
- Ability to travel up to 60% of the time.
- Strong analytical and problem-solving skills.
- Ability to work effectively in a team environment.
Compensation and Benefits
We offer a competitive salary range of €80,000 - €120,000 per year, depending on experience, plus a comprehensive benefits package including health insurance, retirement plan, and generous paid time off.
About Novartis Farmacéutica
Novartis Farmacéutica is a leading pharmaceutical company dedicated to developing innovative treatments for patients worldwide. We are committed to improving healthcare outcomes and transforming lives through our research, development, and commercialization of medicines.
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