Pharmaceutical Affairs Manager - Nordics

At CSL Vifor we have established a new organizational model for managing local country organizations (CSL Vifor affiliates) and distribution partners. In this context, we are offering an exciting opportunity for our Quality GDP, Affiliates & Partners Management organisation: 

The position includes role as Responsible Person (RP) and Quality Manager for wholesale distribution of pharmaceutical products in country organization (affiliate) and (distribution) partners. In this role, you report directly to the Lead Quality Affiliate & Partners EU with dotted line to the Global Regulatory Affairs organisation.

You are responsible for ensuring the quality and regulatory compliance for the distribution of pharmaceutical products by CSL Vifor affiliate and partners in the Northern countries as Sweden, Denmark, Norway, Finland and Iceland. Furthermore, you will be responsible for the following tasks:

Responsible Person for Wholesale & Affiliate Quality Manager:

• Take full responsibility as Responsible Person (RP) for wholesale in Sweden with regularly working on site including 24/7 availability

• Ensure compliance with all cGDP regulations and guidelines to ensure the quality, integrity and safety of pharmaceutical products throughout the distribution chain

• Ensures that the local QMS is implemented and maintained

• Ensure inspection readiness of affiliate and distribution partners

• Communicate with Health Authorities regarding wholesale and MAH topics

• Fulfill quality manager tasks and responsibilities for distribution of pharmaceutical products in the Nordic countries: Denmark, Sweden, Norway, Finland und Iceland

• Manage complaints, deviations, recalls, changes as well as CAPAs for Quality-related issues.

• Manage external consultants that provide managed Quality services.

• Organize and lead annual management review meetings.

• Organize and conduct training for internal and external people

• Prepare for and lead internal and external audits/inspections.

Medical Affairs / Regulatory Affairs:

• Update internal and external product databases to ensure the use of the latest approved product information.

• Control and approve mock-ups/regulatory artworks for print.

• Efficiently communicate regulatory information internally, such as product information updates or market launches.

The position is divided equally into ca. 50% QA (RP included) and 50% RA/Medical Affairs tasks and responsibilities

Qualifications and experience:

• Pharmacist or similar education, fulfilling requirements for registration as Responsible Person for WDA in Sweden

• At least 5 years of experience in the pharmaceutical industry

• Experience as quality manager in the Nordic markets.

• Strong knowledge of applicable regulations in wholesale and quality.

• Proficiency in Swedish and professional level in English, both oral and written.

• Proficient in Quality IT-systems and MS Office.

• Excellent communication skills with the ability to communicate efficiently and productively both orally and in writing.

Preferred Requirements:

• Experience with Nordic product databases (e.g., LiiV, Felleskatalogen, DKMAnet).

• Experience in importing medicinal products into Sweden and knowledge of Swedish regulations.

About CSL Vifor

CSL Vifor aims to become the global leader in iron deficiency and nephrology.

The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

For more information, please visit viforpharma.com

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