Lead Auditor

Lead Auditor (Senior), External Supplier Quality

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/third-party 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

1. 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.
2. 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 follow-up.
3. Responsible for interpreting and making decisions based on company policies/procedures, regulatory agencies, local, state, federal and international regulations.
4. 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 executed per expected timelines.
5. Responsible for the development, implementation and maintaining oversight of the Global Supplier Audit Schedule and other Supplier Management tools.
6. Bring/maintain the suppliers/third parties to the expected level of compliance.

Key Tasks

1. Local Point of Contact for External Supplier Quality (ESQ) organization.
2. Plan, execute and follow-up assigned audits.
3. Revise, edit and route for signature Quality Agreements as assigned.
4. Supplier-related complaints follow-up (tracking, investigation completion and proper CAPA plan).
5. Supplier improvement plans where applicable.

Your Profile

Minimum Requirements

1. Requires a four-year degree in a relevant business or science, or equivalent education and experience.
2. Minimum of 5 years’ experience in a GxP environment in the pharmaceutical industry.
3. At least 5 year-experience in a QA role in a pharmaceutical company, including global and/or regional audit responsibility.
4. Thorough understanding of required regulations including but not limited to FDA, PiC/S and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc.
5. Strong industry and auditing knowledge (internal and external), with relevant evidence.
6. Demonstrated knowledge of Quality Systems and Supplier Management required.
7. Must be comfortable working in a global, matrix organization.
8. Fluent in English (written and spoken). Other languages (German, French) would be an asset.

Preferred Requirements

1. Experience facilitating a cross-functional team.

Are you interested in this exciting opportunity? We are looking forward to receiving your online application.

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

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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 click here.