Quality Affiliates & Partners QA Manager
Publication date:
09 August 2024Workload:
100%Contract type:
Unlimited employment- Place of work:St. Gallen
At CSL Vifor we have established a new organizational model for managing local country organisations (CSL Vifor affiliates) and partners. In this context, we are offering an exciting opportunity for our Quality GDP, Affiliates & Partners Management:
Quality Affiliates & Partners QA Manager
In this role you will report into the Head of Quality GDP, Affiliates & Partners Management. You will be responsible for providing best QA support for our affiliates and partners. Furthermore, you will be responsible for the following tasks:
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Ensuring inspection readiness of affiliates
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Maintain and improve compliance of the Affiliate Quality Management Systems (QMS) with company policies, industry standards, and local GMP/GDP regulations
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Ensuring compliance of local product supply in cooperation with Regulatory, Legal, and other internal and external stakeholders
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Writing, review, and management of Quality agreements
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Support for regulatory submissions and variations in close cooperation with global and local stakeholders
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Auditing affiliates, partners and third parties as warehouses, logistic service providers etc.
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Support affiliates and partners in any launch and supply related activities
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Creating, Review and approval of compliance records (Changes, complaints, deviation) and other documents
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Providing overview about Quality System Performance of affiliates and partners
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Support in training management for affiliate team members
Qualification and experience
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Bachelor / Master Degree in Life Sciences or related industries or working experience in pharmaceutical Industry
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Minimum 3 years overall experience within the pharmaceutical, biotechnology, or medical device industry
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Experience in Quality Assurance
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Experience in regulatory inspection management and ideally interactions with health authorities
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Experience with software for Quality processes (e.g. Trackwise)
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Strong organisational skills with the ability to manage multiple priorities and timelines
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Team player
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Fluent in English, German and or other languages are an asset
Preferred Requirements
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working experience in different cultures
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experience in auditing
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knowledge of different local pharmaceutical legal requirements
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Management of trainings in electronic systems
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
CSL Vifor is committed to provide equal employment opportunity for all.
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
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Vifor!
Contact
Vifor (International) AG