Aktuelle Jobs im Zusammenhang mit Audit and Quality Manager - St Gallen, Sankt Gallen - CSL Vifor
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Audit and Quality Manager
vor 3 Wochen
About CSL Vifor
CSL Vifor aims to become the global leader in iron deficiency and nephrology. We strive to help patients around the world with severe, chronic, and rare diseases lead better, healthier lives.
Our Mission
We specialize in strategic global partnering, in-licensing, and developing, manufacturing, and marketing pharmaceutical products for precision patient care.
The Role You'll Play
You will support the local site regarding supplier/third-party qualification status and process and report directly to the Head of Supplier Quality Management (CH). We are offering a flexible and hybrid working model.
What You'll Do
- 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.
- 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.
- 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 executed 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.
Requirements
- Four-year degree in a relevant field, such as business, engineering, or science.
- Minimum five years of experience in a GxP environment in the pharmaceutical industry.
- Proven track record in auditing, regulatory compliance, and supplier management.
- Strong analytical and problem-solving skills, excellent communication and interpersonal skills.
- Knowledge of quality management systems, supply chain management, and GxP regulations.
- Fluency in English (written and spoken), with proficiency in additional languages a plus.
