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 transform 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.
The purpose of the position is to perform GMP GDP Audits (GMP, GDP,) and contribute to develop and maintain
the global Sobi GMP GDP audit strategy and audit program(s). The audits will be both 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 have the main responsibility for the administration of audits and audit programs and plannings
in the computerised systems at Sobi.
Key Responsibilities
- 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.
- Plan, lead, conduct, document, and follow-up of 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 (as well as applicable
regulations, standards, quality agreements, and guidance documents) working ins strong collaboration
with the GMP GDP Audit coordinator and relevant stakeholders.
- Lead Auditor or Co Auditor of internal audits/self-inspections within Sobi’s QMS as well as
- Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the
proposed filing
- Ensure appropriate escalation to responsible management in case of critical findings and support
immediate follow-up. Ensure adequate definition and recording of mitigation plans when applicable.
- Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the GMP GDP Audit
coordinator and other stakeholder QA representative and Auditee.
- Prepare regular status report on performed GMP GDP audits (Primarily dedicated to GMP/GDP), audit
trending and agreed upon metrics to ensure oversight.
- Support Authority inspections and partner audits
- Maintain knowledge of company policies, SOPs, and supporting documents related to drug
development/manufacturing/distribution as well as FDA and EU regulations and ICH guidance documents
(as applicable) along with any other national or international regulations
- SOP Author for SOPs related to GMP GDP audits including supporting documents Act as GMP GDP
compliance consultant for GMP GDP trainings, task forces, continuous improvement projects as needed.
- Act as GMP GDP compliance consultant for GMP GDP trainings, task forces, continuous improvement projects as needed.
Education/Learning Experience/Work Experience
· University degree in Life Sciences or related discipline.
· At least 10 years’ experience from the pharmaceutical industry with GMP/GDP responsibilities.
· Experience of Lead GMP GDP audits/inspections.
· Experience working as GMP GDP Inspector, or Auditor in the field of Biotechnology and Sterile
Manufacturing
Skills/Knowledge/Languages
· Excellent knowhow of the EU/US/RoW regulations within GMP GDP
· Excellent verbal and written communication skills
· Excellent knowledge in document handling in computerised systems
Personal Attributes
· Delivery focus
· Collaborative
· Structured and detail oriented
· Strong individual initiative, organizational/people skills and multi-tasking abilities
· Ownership, paternership and sense of urgency
Additional Comments
The position require ability and willingness to travel in connection with performing on-site audits.
How to apply
At Sobi, we value work-life balance and due to the holidays, it may take a little bit longer until you here back from us.
We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.
Why Join Us?
Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:
We are a global company with over 1,800 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.
Sobi Culture
At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.
As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.
