Role & seniority: Quality Assurance Manager (GCP) – senior QA lead within Quality unit

Stack/tools: GCP, PV, GLP regulatory frameworks; QMS documentation; CAPA, change control, audit management; training coordination; risk-based QA strategy

Top 3 responsibilities

Provide QA oversight for GCP/PV/GLP activities at company and vendor/investigator sites; act as QA contact for related studies
Support QMS continuous improvement; establish/update QMS documents; manage non-conformances, investigations, CAPAs, change control
Prepare, conduct and follow up audits/inspections; ensure audit findings are tracked/reported; coordinate internal/external training; support inspection readiness

Must-have skills

University degree in pharmacy/chemistry or equivalent; 10+ years pharma experience; 5+ years QA GCP
Excellent GCP/PV knowledge; auditing GCP, PV, GLP; experience with Health Authority inspections (FDA, BfArM)
Regulatory writing experience (IMPDs, INDs); strong organizational, analytical, and communication skills; English fluent

Nice-to-haves

Auditor qualification
Additional language skills
Location & work type: Switzerland-based; willingness to travel for audits (travel required)

Full Description

We are looking for...

....a highly motivated Quality Assurance Manager GCP for our Quality unit.

Your tasks

Provide QA oversight for GCP/PV/GLP activities within the company and at vendor/investigator sites for assigned studies/ compounds Act as QA contact person for vendors/investigator sites for related GCP/PV/GLP studies Support continuous improvement of the Quality Management System (QMS) and related processes, including establish and update QMS documents Contribute to a risk-based strategy for QA activities (GCP/PV/GLP) Ensure timely and appropriate management of non-conformances related to relevant GCP/PV/GLP deviations, quality issues, investigations, CAPAs, and change control Support inspection readiness of Basilea and Vendors conducting GCP, PV, and GLP activities through review audit findings, CAPA generation and review, and training Support preparation, conduct and follow up of audits and inspections at client sites and partners as required Ensure audit results are formally tracked, recorded and reported Coordinate and lead internal or external training activities Willingness to travel for audits

Your profile

University degree in pharmacy, chemistry or equivalent, an auditor qualification would be an asset Minimum 10 years of experience in the Pharmaceutical industry and a minimum of 5 years’ experience in QA GCP Excellent knowledge of GCP and PV legislation and experience in auditing GCP, PV and GLP Experience in GCP/GVP related Health Authority Inspections (FDA, BfArM) Familiar with writing/reviewing sections of regulatory documents (IMPDs, INDs) Ability to work both independently and collaboratively, well-organized and structured with excellent technical and analytical skills Excellent communication and presentation skills at different levels Fluency in English written and spoken is essential, any other language would be beneficial

Why us?

Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on inspiring, cross-functional projects in an engaging working environment. We strongly believe that every employee can make an impact and is vital to our success. If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application. Additional information can be found on our website www.basilea.com.

About us

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea has about 150 employees. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba® for the treatment of invasive fungal infections and Zevtera® for the treatment of bacterial infections. In addition, we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Show more Show less