GVP Quality Lead
3 days ago
Job Description
The Senior PV Quality Manager will be responsible for ensuring the overall quality of Ascendis Pharma's PV activities. This includes performing GVP audits, reviewing and analyzing audit data, and providing expert compliance and regulatory advice.
The ideal candidate will have a strong background in quality assurance, preferably in the pharmaceutical industry, and excellent communication skills. They should be able to work independently and collaboratively as part of a global team.
Key Responsibilities
- GVP Audits: Plan, perform, and report on GVP audits in collaboration with internal and external stakeholders.
- Audit Data Analysis: Review and analyze audit data to identify root causes, compliance trends, and areas of exposure related to GVP.
- Compliance Reporting: Prepare periodic compliance metric reports and conduct non-compliance investigations.
- Regulatory Advice: Provide expert compliance and regulatory advice on GVP.
Required Skills and Qualifications
- Master's degree in a scientific discipline.
- Minimum 5-10 years of experience in the pharmaceutical industry with significant experience in GVP.
- GVP Auditor experience in quality systems, compliance monitoring, and SOP development and maintenance.
- Excellent communication and interpersonal skills.
Benefits
We offer an attractive remuneration package, short- and long-term incentives, pension, and health insurance. You can expect around 30 travelling days per year due to international business developments.
Others
This job posting is not suitable for people who prefer routine tasks or limited responsibilities. As a Senior PV Quality Manager, you will be part of a dynamic team that addresses complex challenges and contributes to the company's success.
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