Sr GMP GDP Auditor

The purpose of the position is to perform GMP GDP Audits (GMP, GDP) and contribute to developing and maintaining

the global Sobi GMP GDP audit strategy and audit program(s). The audits will include internal audits/self-inspections within Sobi’s QMS as well as external audits of Sobi’s CMOs, suppliers, and service providers. The employee will also be responsible for the administration of audits, audit programs, and planning in the computerised systems at Sobi.

Key Responsibilities

1. Drive strategic development of an effective global risk-based audit strategy (internal & external) and program. Collect, collate, and incorporate input into the audit strategy and plan.
2. Plan, lead, conduct, document, and follow-up on internal and external GMP GDP audits (primarily dedicated to GMP / GDP) as Lead Auditor or Co-Auditor of Sobi’s CMOs, suppliers, and service providers, according to the requirements specified in the respective Sobi procedures, regulations, standards, quality agreements, and guidance documents, working in strong collaboration with the GMP GDP Audit coordinator and relevant stakeholders.
3. Lead or co-lead internal audits/self-inspections within Sobi’s QMS. Provide regulatory guidance for timely remediation and recommendations regarding the acceptability of the proposed filing.
4. Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up. Define and record mitigation plans when applicable.
5. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the GMP GDP Audit coordinator, QA representatives, and auditees.
6. Prepare regular status reports on GMP GDP audits, including trending and metrics for oversight.
7. Support authority inspections and partner audits.
8. Maintain knowledge of company policies, SOPs, and supporting documents related to drug development, manufacturing, distribution, as well as FDA, EU regulations, and ICH guidance documents.
9. Author SOPs related to GMP GDP audits and supporting documents. Act as GMP GDP compliance consultant for trainings, task forces, and continuous improvement projects.

Qualifications

1. University degree in Life Sciences or related discipline.
2. At least 10 years of experience in the pharmaceutical industry with GMP / GDP responsibilities.
3. Experience in Lead GMP GDP audits / inspections.
4. Experience working as GMP GDP Inspector or Auditor in Biotechnology and Sterile Manufacturing.

Skills / Knowledge / Languages

1. Excellent knowledge of EU / US / RoW GMP GDP regulations.
2. Excellent verbal and written communication skills.
3. Proficiency in document handling in computerized systems.

Personal Attributes

1. Delivery focus.
2. Structured and detail-oriented.
3. Strong initiative, organizational, and interpersonal skills. Ability to multitask.
4. Ownership, partnership, and sense of urgency.

Additional Comments

The position requires the ability and willingness to travel for on-site audits.