CSL Behring - the global biotherapeutics provider driven by its promise to save lives. Our more than 1'400 employees in Bern are committed to developing and delivering live-saving therapies to help people with primary immune deficiencies to live full lives.
For our location in Bern, we are looking for a :
SENIOR AUDITOR - GLOBAL SUPPLIER QUALITY
Main Responsibilities and Accountabilities:
The Senior Auditor travels on a routine basis to perform quality systems audits of approved and/or potential suppliers of raw materials, components, suppliers and service providers for the CSL Sites. The Senior Auditor may also perform local Site audits, as requested. As necessary, the Senior Auditor assists with remote/desk-audits.
The Senior Auditor prepares audit report and assign levels of compliance to each observe action based on established criteria; delivers audit results to suppliers in a professional manner; evaluate supplier corrective action plans are satisfactorily addressing the observation(s).
The Senior Auditor is also responsible for interpreting and making decisions based on company policies/procedures, regulatory agencies, local, state, federal and international regulations.
The Senior Auditor is responsible for supplier quality agreements, global and local, which include writing, editing, reviewing, updating and routing the agreements for approvals between CSL Manufacturing Site, service providers and suppliers.
The Senior Auditor assists the Manufacturing Site as the subject matter expert for Supplier Quality during inspections to mitigate compliance risk to the manufacturing site and to Supplier Quality.
The Senior Auditor does, in collaboration with Sr. Manager / Manager, Regional Supplier Quality, develop individual development plan which cultivates individual and organizational bench-strength. the Senior Audit performs additional tasks as assigned.
Strict minimum of 5 years' experience in a GxP environment in the pharmaceutical industry after studies in life sciences (biology, chemistry, pharmacy, min. Master level).
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 knowledge (of CSL Behring's process flow and the plasma business), and auditing knowledge (internal and external) experiences within the industry.
Must be comfortable working in a global, matrix organization.
Strong organizational skills; managing diversity; time management and planning. Cross-cultural sensitivity, perseverance, written and verbal communication. Decision quality, functional and technical skills.
Fluent in English and German (written and spoken), a must.
This role requires local and overseas travel, 55%-75% travel.
We are looking forward to receiving your complete online application. Applications must include a cover letter and a CV.