QA management of Licence and partner

Job title:

QA management of Licence and partner

Company

CSL

Job description

At CSL Vifor, we are driven by a shared purpose: improving the lives of patients worldwide. To strengthen our Quality Assurance team, we are looking for aQA Management – Licensing & External PartnerIn this role, you will be responsible for ensuring that our licensed and partner-manufactured products meet the highest GMP and regulatory standards.Your Responsibilities

• Manage Licensing/External Partner activities to ensure compliance with GMP guidelines, product registration requirements, and internal SOPs (e.g., MBRs, validation plans/reports, deviations, complaints, change controls).
• Provide quality oversight of GMP data and key performance indicators (KPIs) related to Licensing/External Partners.
• Ensure efficient knowledge management of products manufactured by Licensing/External Partners.
• Collaborate with Regulatory Affairs (CMC) team on regulatory submissions and responses to Health Authority inquiries.
• Actively contribute to continuous improvement initiatives within the QA department.

Functional Responsibilities

• Collect, organize, and analyze manufacturing and control data provided by Licensing/External Partners for products under CSL Vifor responsibility.
• Serve as the QA representative and active member of project teams involving Licensing/External Partners.
• Coordinate and manage processes such as changes, deviations, OOX investigations, and CAPAs in collaboration with cross-functional teams (Supply Chain, Regulatory Affairs, Pharmaceutical Development, Qualified Person).
• Support KPI management, tracking, and reporting to evaluate Licensing/External Partner performance.

Your Qualifications

• Master’s degree in Life Sciences or a related field, or equivalent professional experience in the pharmaceutical industry.
• Minimum of 3–5 years of experience in the pharmaceutical or medical device environment, ideally in Quality Assurance and/or Manufacturing.
• Experience in Parenteral Sterility Assurance or Environmental Monitoring is a strong plus.
• Technical understanding of sterility assurance from both scientific and compliance perspectives.
• Up to date with technological and regulatory developments in the parenteral manufacturing sector (e.g. aseptic filling, Annex 1).
• Excellent communication and negotiation skills with external stakeholders and contract manufacturing organizations.
• Strong detail-oriented, planning and organizational skills.
• A collaborative team player with a solution-oriented and proactive mindset.
• Fluency in English is required; other language skills are advantageous.

Preferred Requirements:

• Experience in working with Licensing or External Manufacturing Partners.
• Familiarity with stability study management.
• Prior involvement in regulatory inspections and health authority interactions.
• Understanding of KPI systems and performance monitoring tools.

We are looking for a solution-oriented, proactive individual who enjoys continuous improvement and is eager to contribute meaningfully to our QA organization.Does this sound like you? Then we look forward to receiving your online application. Please upload your CV, employment references, and copies of diplomas (in original language and/or relevant transcripts) as one single document.Join us in our mission to make a meaningful difference in patients’ lives.About CSL ViforCSL 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.comWe want CSL to reflect the world around usAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more .Do work that matters at CSL Vifor!

Expected salary

Location

Suisse

Job date

Sat, 19 Jul 2025 07:15:38 GMT

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