(Sr.) Specialist External Supplier Quality
Responsibilities:
Local Point of Contact for External Supplier Quality (ESQ) organization.
Revise edit and route for signature Quality Agreements as assigned.
Quality supplier Management (Supplier-related complaints/deviations follow-up (tracking investigation completion and proper CAPA plan acceptance).
Supplier improvement plans where applicable.
May support local site audits as requested
Makes decisions based on company policies/procedures and local state federal and international regulatory requirements
Supports supplier quality agreement activities and works closely with other team members to ensure all agreements are executed per expected timelines
Contributes to development and maintenance of global supplier audit schedule and other supplier management tools
* Local Point of Contact for External Supplier Quality (ESQ) organization.
* Supplier enrollment/qualification facilitation.
* Revise edit and route for signature Quality Agreements as assigned.
* Supplier performance monitoring
* Quality supplier Management (Supplier-related complaints/deviations follow-up (tracking investigation completion and proper CAPA plan acceptance).
* Supplier improvement plans where applicable.
* May support local site audits as requested
* Makes decisions based on company policies/procedures and local state federal and international regulatory requirements
* Supports supplier quality agreement activities and works closely with other team members to ensure all agreements are executed per expected timelines
* Contributes to development and maintenance of global supplier audit schedule and other supplier management tools
Qualifications:
* Degree in a relevant business or science or equivalent education and experience.
* Minimum of 5-8 years experience in a GxP environment in the pharmaceutical industry.
* Thorough understanding of required regulations including but not limited to FDA PiC/S and European regulation Therapeutics Goods Authority Canadian Health Authority etc.
* Demonstrated leadership and knowledge of Quality Systems and Supplier Management required
* Must possess thorough knowledge of global cGMP regulations and ISO standards
* Demonstrated knowledge of Quality Systems and Supplier Management required.
* Must be comfortable working in a global matrix organization.
* Fluent in English (written and spoken). Other languages (German French) would be an asset.
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.
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative leading therapies in irondeficiency and nephrology. We specialize in strategic global partnering in-licensing and developing manufacturing and marketing pharmaceutical products for precision healthcare aiming to help patients around the world lead better healthier lives. Headquartered in St. Gallen Switzerland CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being CSL.
You Belong at CSL
At 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.
To learn more about inclusion and belonging visit Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:
Senior IC
Key Skills
Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP
Employment Type : Full-Time
Experience: years
Vacancy: 1
Sr Specialist External Supplier Quality Switzerland • Saint Gallen, St. Gallen, Switzerland
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