GCP Auditor based in Europe

Job description

Job Description

- Contribute to the development of an effective risk-based audit strategy and programme 
- Lead, plan, perform, conduct, follow-up and document global quality regulatory compliance audits and assessments of Good Clinical Practice and safety reporting practices within Novartis Pharma.
- Provide technical guidance and training on audit activities. 
- Prepare audit reports according to Novartis requirements and timelines 
- Review, evaluate and approve proposed corrective and preventive action plans (CAPA) in collaboration with the responsible business unit.
- Contribute to generation of audit metrics. 
- Identify and communicate quality and regulatory compliance issues to GCP QA Audit management through appropriate channels.
- Provide assistance with the remediation of compliance concerns; determine effectiveness of remediation activities; and provide on-going project support and governance, as assigned. 
- Support GCP QA Audit with compliance investigations and initiatives focused on inspection readiness and quality, process and compliance improvement. 
- Review and advise on relevant guidelines, policies, Novartis Internal Procedures and SOPs (Standard Operating Procedures).
- Prepare and conduct GCP and audit related training
- Deliver presentations to QA and business partners
- Attend relevant Novartis Pharma QA and quality- related meetings
- Issue escalation where appropriate

Desired profile

- Degree in natural/biological sciences or equivalent (or an equivelent mix of education and experience)
- English fluency at operational and functional level (as first or second language; second language a plus)
- Guideline of 7-10 years GCP/clinical/industry/health authority experience or equivalent
- 1-2 years of GCP auditing experience
- Prepared to travel up to 60%
- Ability to manage and objectively evaluate compliance issues
- Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision making and problem solving
- Experience with Health Authority inspections and interaction a plus
- Good quality and compliance leadership and facilitation skills
- Excellent verbal and written communication, organizational and interpersonal skills
- Excellent computer skills, including Excel, Word, etc
- Thorough knowledge of applicable GCP, PV and GxP regulations, guidelines, policies and procedures
- Good knowledge of computer validation and Part 11 requirements
- Ability to operate successfully in various team capacities, including leader and/or active member
- location of the role: the role will not be based in Basel - location is flexible in EU.