Location: Germany - Munich
Seniority Level: Manager
In view of our continued new product launches as well as to support the current portfolio we are looking for further support and are recruiting our new CQA Auditor/Manager based in our affiliate in Munich. In this position you are responsible for supporting the regulatory compliance of Vifor Pharma’s clinical studies.
Reporting to the Head of CQA Auditing your main missions are as follows:
- Independently schedule, prepare and conduct external & internal audits in the GCP area (including on-site and/or remote investigator site, vendor, laboratory, process and system audits), as well as respective reporting and follow up of CAPAs.
- Audit of directed and for-cause audits as necessary.
- Act as CQA Auditing representative for study documents compliance verification and in designated study team/s as well as provide internal guidance and consulting for trial GCP issues.
- Involvement in CQA audit CAPA management (tracking, oversight, follow-up).
- Audit generated documentation management and maintenance.
- Keep Head CQA Auditing apprised of compliance and other issues through periodic reports.
- Generate and provide metrics, status reports and other information in relation with GCP, as required by management.
- Write and contribute to the review of Clinical Medical, Regulatory, Safety (CMRS)-related and corporate quality SOPs, as well as monitor and assess clinical processes and SOPs for consistency with laws, regulatory requirements and Vifor Pharma policies and procedures.
- Comply with all corporate policies, rules, and regulations as set out and communicated by the company pursuant to good business practice.
- Perform other duties as assigned, e.g. GCP training, support of Head QM CMRS, Head CQA Auditing and Head PV QA in Regulatory Authority inspection preparation, conduct and post-inspection activities.
The ideal candidate will have a university degree in a relevant field in addition to the following:
- 2 to 5 years of experience in GCP auditing with FDA/EMA/Global regulatory requirements and ICH guidelines
- Experience in regulated environment, preferably pharmaceutical industry.
- Big interest in business related travels (minimum 20%) and flexibility in this regard
- Independent at work in the GCP audit area
- Fluency in English is a must for your everyday job, German would be a plus
You describe yourself as a flexible, organized and detail oriented person who enjoys to work autonomously and who likes to have audit related business trips. Stakeholder management, being in touch with a lot of people and working according to strict principles and values are things you regard as your strengths.
If this sounds like you please do apply to this new position with us at Vifor Pharma.
This position is for an 18 months contract that is planned to transform into a permanent contract after successful completion of this contract.
The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.
Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit www.viforpharma.com/career