Senior GxP Auditor at Sobi

Sobi is looking for a Senior GxP Auditor to support the strategic development of a global, risk-based audit strategy. This role is key to ensuring compliance with GMP/GDP regulations while collaborating with cross-functional teams to maintain the highest standards in quality and regulatory compliance.

Key Responsibilities

• Develop and support a global risk-based audit strategy and program.
• Plan, lead, conduct, document, and follow up on external GxP audits of CMOs, suppliers, and service providers.
• Perform internal audits/self-inspections as Lead or Co-Auditor.
• Provide regulatory guidance and recommendations for compliance.
• Escalate critical findings and ensure appropriate corrective and preventive actions (CAPA).
• Prepare regular audit status reports, including audit trends and performance metrics.
• Support authority inspections and partner audits.
• Maintain expertise in FDA, EU, and ICH regulations as well as internal quality standards.
• Act as an SOP Author for GxP audit-related SOPs.
• Provide GxP compliance consulting for training, continuous improvement projects, and task forces.Qualifications & Experience:

• University degree in Life Sciences or a related field.
• Minimum 10 years’ experience in the pharmaceutical industry with GMP/GDP responsibilities.
• Strong background in GMP/GDP audits/inspections.
• Experience as a GMP Inspector or Auditor in Biotechnology and Sterile Manufacturing (Drug and Finished Products); Drug Substance experience is preferred.

Skills & Attributes:

• Excellent knowledge of EU/US/RoW GMP/GDP regulations.
• Strong verbal and written communication skills.
• Proficiency in document management systems.
• Structured, detail-oriented, and collaborative mindset.
• Ability to multi-task and manage priorities effectively.

Location: Switzerland/Sweden (Remote with office availability on demand)Start Date: March 3, 2025Contract: 12 months, full-time

About Clevry

For over 30 years we have been the change maker for a more soft skills driven work-life within talent acquisition, assessments and advisory. We operate globally with customers, consultants and candidates from North America to Singapore with headquarters in Brighton, Stockholm and Helsinki. At Clevry we have over 150 soft skills certified recruiters, business psychologists and experts at your service.

The process

Clevry thinks your soft skills are as important as your hard skills. Do you want to know more about your soft skills and how to optimize them?

As you apply for this position you have the possibility to answer a questionnaire from us about your soft skills. The questionnaire takes approximately 10 minutes to fill out and generates a feedback report (in Swedish) that highlights your soft skills. This report can be used for both personal and professional purposes.

Both questionnaire and feedback report are sent to your e-mail inbox.

We screen candidates continuously and the position could be filled prior to last application date. If you have any questions regarding this position or this recruitment process. Does this role sound like a good match? Please apply today.

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