Job Description:
Global Senior GCP/PV Auditor
Would you like to be a key part of the global auditing team at Novartis, building upon and maintaining our exceptional standards?
As a Global Senior GCP/PV Auditor, you will be responsible for leading, supporting, and reporting on independent GCP and PV audits, and approving follow-up CAPAs according to Novartis guidelines and GCP regulations.
Your responsibilities include, but are not limited to:
1. Supporting the development of an effective global risk-based audit strategy and plan.
2. Leading, planning, conducting, documenting, and following-up on global quality regulatory compliance audits and assessments of GCP/GPvP according to Novartis Quality Modules and applicable regulations, standards, and guidance documents.
3. Providing technical guidance, leadership, mentoring, and training to other auditors.
4. Assessing the adequacy of responses (CAPA plans) to audit findings in cooperation with FURP and QARP.
5. Identifying and communicating quality and regulatory compliance issues to management and recommending remediation actions.
6. Leading compliance investigations and initiatives focused on inspection readiness and quality improvements.
7. Proactively researching local and global initiatives, trends, and events impacting compliance.
8. Maintaining current knowledge of regulations, standards, and guidance documents.
Commitment to Diversity & Inclusion: Novartis is committed to building an inclusive work environment and diverse teams.
Minimum Requirements:
* Approximately 7+ years of experience in GCP or PV; experience in both is advantageous.
* Willingness to travel up to 60%.
* Experience with Health Authority inspections.
* Strong knowledge of GCP, PV, GxP regulations.
* Good knowledge of computer systems validation and 21CFR Part 11.
* Ability to lead audit teams and work effectively in various team roles.
* Fluency in English (written and spoken); additional languages are a plus.
Location: Flexible, near an international airport.
Benefits: Competitive salary, annual bonus, pension scheme, health insurance, flexible working, subsidized dining, recognition schemes.
Why consider Novartis? In 2020, our products touched 769 million lives. We aim to improve and extend even more lives through digital innovation and collaborative effort.
Division: Novartis Technical Operations
Business Unit: NTO QUALITY
Country: Spain
Work Location: Madrid
Company: Novartis Farmacéutica, S.A.
Functional Area: Quality
Job Type: Full Time
Employment Type: Regular
Shift Work: No
Early Talent: No
Please note: Non-citizens may need a work permit. Do not provide bank details when applying. Apply via the 'Apply now' button.
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