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At Sobi, the work we do every day redefines the standards of care and transforms the lives of people living with rare diseases.
As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly, and always challenging the status quo.
We are committed to an inclusive, sustainable, and flexible workplace that fosters growth and development.
Job Description
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 both internal audits/self-inspections within Sobi’s QMS and external audits of Sobi’s CMOs, suppliers, and service providers. The employee will also be responsible for the administration of audits and audit programs 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 of internal and external GMP GDP audits (Primarily 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, in collaboration with the GMP GDP Audit coordinator and relevant stakeholders.
3. Lead or co-lead internal audits/self-inspections within Sobi’s QMS.
4. Provide regulatory guidance for timely remediation and recommendations regarding the acceptability of the proposed filing.
5. Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up. Define and record mitigation plans when applicable.
6. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the GMP GDP Audit coordinator and other stakeholders.
7. Prepare regular status reports on GMP GDP audits, audit trending, and metrics to ensure oversight.
8. Support authority inspections and partner audits.
9. Maintain knowledge of company policies, SOPs, and supporting documents related to drug development, manufacturing, distribution, and regulations (FDA, EU, ICH).
10. Author SOPs related to GMP GDP audits and act as a GMP GDP compliance consultant for trainings, task forces, and continuous improvement projects.
Qualifications
Education/Learning Experience/Work Experience
* University degree in Life Sciences or related discipline.
* At least 10 years’ experience in the pharmaceutical industry with GMP/GDP responsibilities.
* Experience in leading GMP GDP audits/inspections.
* Experience as a GMP GDP Inspector or Auditor in Biotechnology and Sterile Manufacturing.
Skills/Knowledge/Languages
* Excellent knowledge of EU/US/RoW GMP GDP regulations.
* Excellent verbal and written communication skills.
* Proficiency in document handling in computerized systems.
Personal Attributes
* Delivery focus
* Structured and detail-oriented
* Strong initiative, organizational and people skills, and multi-tasking abilities
* Ownership, partnership, and a sense of urgency
Additional Comments
Willingness to travel for on-site audits.
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