Quality Audit & Supplier Qualification

CSL; Sankt Gallen; Hybrid; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

A leading company in pharmaceuticals is seeking a Senior Auditor for their Quality team in St. Gallen. This permanent role involves conducting supplier audits, managing quality agreements, and ensuring compliance with industry regulations. Join CSL to drive quality and enhance supplier performance in a collaborative environment.

Qualifikationen

• Minimum 3 years’ experience in a GxP environment within the pharmaceutical industry.
• Thorough understanding of regulations such as FDA, PiC/S, and European regulations.
• Comfortable working in a global, matrix organization.

Aufgaben

• Conduct remote/desk audits of approved and potential suppliers.
• Prepare audit reports and evaluate supplier corrective action plans.
• Manage supplier quality agreements including writing and routing for approvals.

Kenntnisse

Understanding of regulations

Knowledge of industry and auditing practices

Fluent in English

Ausbildung

Four-year degree in a relevant field

Jobbeschreibung

Title: Auditor (Senior), External Supplier Quality

Type of role: Permanent position

We are looking for a (Senior) 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. Conduct remote/desk audits of approved and potential suppliers of raw materials, components, suppliers, and service providers for CSL Sites. May also perform local Site audits.
2. Prepare audit reports, assign compliance levels based on established criteria, and deliver results to suppliers within CSL timelines. Evaluate supplier corrective action plans to ensure issues are addressed and follow-ups are completed.
3. Interpret and make decisions based on company policies, procedures, and applicable regulations from regulatory agencies, local, state, federal, and international authorities.
4. Manage supplier quality agreements, including writing, editing, reviewing, updating, and routing for approvals between CSL Sites, service providers, and suppliers.
5. Maintain suppliers/third parties at the required compliance levels.

Key Tasks

1. Serve as the local point of contact for External Supplier Quality (ESQ) organization.
2. Plan, execute, and follow up on assigned audits.
3. Revise, edit, and route Quality Agreements for signature as assigned.
4. Follow up on supplier-related complaints, including tracking, investigation, and CAPA planning.
5. Implement supplier improvement plans where applicable.

Your Profile

1. Hold a four-year degree in a relevant business or science field, or equivalent education and experience.
2. Minimum of 3 years’ experience in a GxP environment within the pharmaceutical industry.
3. Thorough understanding of regulations such as FDA, PiC/S, European regulations, Therapeutics Goods Authority, Canadian Health Authority, etc.
4. Knowledge of industry and auditing practices, both internal and external.
5. Comfortable working in a global, matrix organization.
6. Fluent in English (written and spoken); proficiency in German or French is a plus.

Preferred Requirements

1. 3-5 years of QA experience in a pharmaceutical company, including global or regional audit responsibilities.
2. Knowledge of Quality Systems and Supplier Management.
3. Experience with sterile and non-sterile product manufacturing, biological processes, laboratory operations, and distribution.
4. Ability to interact effectively with senior management, global partners, and cross-functional teams.
5. Deep knowledge of the regulatory environment for drug manufacturing.

Interested and see yourself in this profile? We look forward to receiving your online application.

About CSL Vifor

CSL Vifor aims to become the global leader in iron deficiency and nephrology. The company partners with organizations for pharmaceuticals and patient-focused solutions across iron, dialysis, nephrology, and rare conditions. CSL Vifor strives to help patients worldwide with severe, chronic, and rare diseases lead better, healthier lives. It specializes in global partnerships, licensing, development, manufacturing, and marketing of pharmaceutical products for precision patient care.