Company Description
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!
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 programs. 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 and audit programs in the computerised systems at Sobi.
Key Responsibilities
* Drive strategic development of an effective global risk-based audit strategy (internal & external) and audit program. Collect, collate, and incorporate input into the audit strategy and plan.
* 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 collaboration with the GMP GDP Audit coordinator and relevant stakeholders.
* 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.
* Ensure appropriate escalation to management in case of critical findings and support immediate follow-up. Define and record mitigation plans when applicable.
* Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the GMP GDP Audit coordinator and other QA stakeholders.
* Prepare regular status reports on GMP GDP audits, including trending and metrics to ensure oversight.
* Support authority inspections and partner audits.
* Maintain knowledge of company policies, SOPs, and supporting documents related to drug development, manufacturing, and distribution, as well as FDA, EU regulations, ICH guidance, and other applicable regulations.
* Develop SOPs related to GMP GDP audits, act as a GMP GDP compliance consultant for training, task forces, and continuous improvement projects.
Qualifications
* University degree in Life Sciences or a related discipline.
* At least 10 years of experience in the pharmaceutical industry with GMP/GDP responsibilities.
* Experience conducting 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 within computerized systems.
Personal Attributes
* Delivery-focused
* Collaborative
* Structured and detail-oriented
* Strong initiative, organizational skills, and multi-tasking abilities
* Ownership, partnership, and sense of urgency
Additional Comments
The position requires the ability and willingness to travel for on-site audits.
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