International QA Auditor for CMO and Pharma Supply

Manufacturing - Distribution - Biologics - Steriles - Basel

--- | Ready for a very independent and responsible role in small pharma? Travel through Europe for GxP audits at partners and suppliers. Liase with internal and external stakeholders and be part of the virtual Biotech vision of our client in Basel. The role requires a 60-70% travelling in the EU and sometimes US/Asia. The position can be remote with strong bonds to Basel offices. Key Responsibilities * Support the strategic development of an effective global risk-based audit strategy

• Plan, lead, conduct, document, and follow-up of assigned GMP/GDP audits as Lead Auditor
• Manage Global, Regional, and Affiliate internal audits/self-inspections
• Manage external audits of CMOs, CLOs, contract service providers and suppliers
• Provide regulatory guidance for timely remediation and recommendations of proposed filings

Your Profile * BSc/MSc in Life Sciences

• > 10 years experience from the pharmaceutical industry with GMP/GDP experiences
• Experience with HA and CMO auditing on GMP/GDP/GLP standards
• Experience with sterile products, small molecules and/or medical devices is highly welcome
• Self assured and confident personality with Lead Auditor experience.

Our customer is an innovative international biopharmaceutical company with offices in Basel. Intense R&D activities gave rise to an exciting pipeline of new promising drugs, many of which successfully reached commercialization stage. With a strong portfolio of on-market products, and an extensive portfolio of pre-market assets company covers the entire value chain. Focus is put on late-stage research and development, patient access and commercialisation. This is realised as well with co-development agreements with international big pharma. You are a quality influencer and observer throughout all steps in the multi-site supply network and are talented to build trustful and effective relationships. |