Full-Time Sr GMP GDP Auditor

Position Purpose: Perform GMP GDP Audits (GMP, GDP) and contribute to the global Sobi GMP GDP audit strategy and program development/maintenance. Audits include internal and external (CMOs, suppliers, service providers) evaluations.

Key Responsibilities:

• Drive strategic development of an effective global risk-based audit strategy (internal & external).
• Plan, lead, conduct, document, and follow-up on GMP GDP audits (internal & external) as Lead Auditor/Co-Auditor.
• Provide regulatory guidance for timely remediation.
• Escalate critical findings to management, ensure follow-up, and define/record mitigation plans (if applicable).
• Assess adequacy of responses (CAPA plans) to audit findings.
• Prepare regular status reports on audits and metrics.
• Support Authority inspections and partner audits.
• Maintain knowledge of company policies, SOPs, and relevant regulations (FDA, EU, ICH).
• Create SOPs and act as a GMP/GDP compliance consultant for trainings and projects.

Education/Experience:

• University degree in Life Sciences or related field.
• 10+ years' experience in the pharmaceutical industry with GMP/GDP responsibilities.
• Experience as a Lead GMP GDP Auditor/Inspector.
• Experience with Biotechnology and Sterile Manufacturing.

Skills/Knowledge:

• Excellent knowledge of EU/US/RoW GMP/GDP regulations.
• Excellent verbal and written communication skills.
• Proficiency in document handling within computerised systems.

Personal Attributes:

• Delivery-focused
• Collaborative
• Structured and detail-oriented
• Strong initiative, organizational/people skills, and multitasking abilities
• Ownership, partnership, and sense of urgency

Additional Comments:

• Travel required.

Compensation: $120,000 - $180,000 annually.

Benefits: 401k match, incentives, medical, dental, vision, STD/LTD, life insurance, wellness programs.

Career Growth: Opportunities for advancement.

Innovation/Impact: Contributing to innovative therapies for rare diseases.

Company Culture: Collaborative, patient-first, passionate about making a difference.

Equal Opportunity Employer:

Sobi is an equal opportunity employer.

What is the last date for applying to the job?

Which countries are accepted for this remote job?