Lead Auditor Senior External Supplier Quality
Lead Auditor Senior External Supplier Quality
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Salary Not Disclosed
1 Vacancy
Job Description
We are looking for a (Senior) Lead Auditor External Supplier Quality to join our Quality team in St. Gallen on a permanent basis. You will support the local site regarding supplier/thirdparty qualification status and process and will report directly to the Head of Supplier Quality Management (CH). We are offering a flexible and hybrid working model.
Main Accountabilities
Through remote/desk audit process executes GxP quality systems audits of approved suppliers of raw materials components suppliers and service providers for the CSL Sites. May also perform local Site audits as requested.
Prepares audit report and assigns levels of compliance to each observed action based on established criteria. Delivers audit results to suppliers according to internal CSL timelines. Evaluates supplier corrective action plans to ensure plans satisfactorily address the observation(s) and ensure the corresponding followup.
Responsible for interpreting and making decisions based on company policies/procedures regulatory agencies local state federal and international regulations.
Responsible for supplier quality agreements global and local which include writing editing reviewing updating and routing the agreements for approvals between CSL Sites service providers and suppliers. Works closely with Sr. Auditors/manager to ensure all Quality Agreements are executive per expected timelines.
Responsible for the development implementation and maintaining oversight of the Global Supplier Audit Schedule and other Supplier Management tools.
Bring/maintain the suppliers/third parties to the expected level of compliance.
Key Tasks
Local Point of Contact for External Supplier Quality (ESQ) organization.
Plan execute and followup assigned audits.
Revise edit and route for signature Quality Agreements as assigned.
Supplierrelated complaints followup (tracking investigation completion and proper CAPA plan).
Supplier improvement plans where applicable.
Your Profile
Minimum Requirements
Requires a fouryear degree in a relevant business or science or equivalent education and experience.
Minimum of 5 years experience in a GxP environment in the pharmaceutical industry.
At least 5 yearexperience in a QA role in a pharmaceutical company including global and/or regional audit responsibility.
Thorough understanding of required regulations including but not limited to FDA PiC/S and European regulation Therapeutics Goods Authority Canadian Health Authority etc.
Strong industry and auditing knowledge (internal and external) with relevant evidence.
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.
Preferred Requirements
Experience facilitating a crossfunctional team.
Are you interested in this exciting opportunity We are looking forward to receiving your online application.
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 patientfocused 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 inlicensing and developing manufacturing and marketing pharmaceutical products for precision patient care.
For more information please visit viforpharma
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!
Employment Type
Full-Time
