QA Auditor Compliance Manager

Job Title: QA Auditor Compliance Manager
Location: Allschwil, Switzerland
Schedule: Full-time (100%)
Start Date: ASAP
Contract Duration: 1 Jan 2025 - 31 Aug 2025 (8 months)
Rate: CHF 77.96

Responsibilities:

• Ensure GMP compliance at third-party providers and internal facilities.
• Lead or assist in creating external audit and self-inspection plans.
• Conduct GMP/GDP audits and self-inspections; coordinate scheduling, execution, and follow-ups with teams and suppliers.
• Report critical audit findings to management.
• Develop and maintain Quality Agreements with vendors as needed.
• Collaborate with quality, regulatory, and operational teams to ensure understanding and implementation of compliance requirements.
• Review and approve change controls, deviations, and CAPAs for internal facilities.
• Write, review, and approve SOPs and GMP/GDP compliance documentation.
• Oversee equipment qualification, calibration, and validation.
• Support Regulatory Authority Inspections.
• Contribute to quality system optimization, key performance metrics, and QMR meetings.
• Promote GxP and a Quality mindset across the organization.
• Occasional travel (20%-30%), including internationally.

Requirements:

• University degree in Pharmacy, Chemistry, or related technical/science field (Master's level minimum).
• At least 3 years of auditing experience, with 1 year as Lead Auditor.
• Strong understanding of drug development, manufacturing, and quality control processes.
• In-depth knowledge of GMP/GDP, international regulations (ICH, ISO, FDA, EU GMP, WHO, PIC).
• Ability to manage multiple projects and prioritize effectively.
• Strong attention to detail, organizational skills, and ability to work with diverse teams.
• Proactive leadership in quality compliance activities.
• Self-confidence, assertiveness, and excellent interpersonal skills.
• Fluent in English; basic knowledge of another European language (German/French) is a plus.