12-Month Contract for CMO Management in Biologics
We seek an independent and responsible professional to support our client's small pharma vision in Basel. The role requires 60-70% travel within the EU, with occasional trips to the US and Asia. You will be based in Basel, with opportunities to work remotely.
Key Responsibilities:
* Develop a global risk-based audit strategy
* Plan, lead, conduct, document, and follow-up on assigned GMP/GDP audits
* Manage internal audits/self-inspections globally, regionally, and at affiliates
* Oversee external audits of CMOs, CLOs, contract service providers, and suppliers
* Provide regulatory guidance for timely remediation and proposed filings
Your Profile:
* Bachelor's or Master's degree in Life Sciences
* 10 years of experience in the pharmaceutical industry with GMP/GDP expertise
* Auditing experience with HA and CMOs on GMP/GDP/GLP standards
* Experience with sterile products, small molecules, and/or medical devices is highly valued
* A self-assured and confident personality with Lead Auditor experience
Our client is an innovative international biopharmaceutical company with offices in Basel. With a strong focus on late-stage research and development, patient access, and commercialization, they cover the entire value chain. This includes co-development agreements with international big pharma.