Global Quality GVP Manager

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.

Job Description

The Global Quality GVP Manager mission is toensure quality oversight and quality assurance activities related to GVP area and guide and support from a quality perspective the global and local, as applicable, PV activities within Sobi

Key responsibilities include in particular:

• Contribute to the development of the audit strategy & program and plans related to the GVP area-PV processes, vendors, Partners and affiliates
• Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head
• Perform and coordinate PV audits internally and externally and act whenever needed as delegated by Global Quality GCP/GVP Head
• Support and collaborate with GPV organization and the safety interfaces such as Medical Affairs, Regulatory Affairs and Affiliates, as applicable
• Ensure qualification of global and local ESP, as applicable in GVP regulated area per Sobi procedures
• Act as QA representative in PV Inspections and different initiatives or projects as needed
• Ensure GVP Audits management excellence of the end-to-end audit management process and overview of the assigned audits, as planned
• Assess and approve from quality perspective the PV deviations (global and local, as applicable), PV related CAPAs.
• Prepare regular status report on performed audits, audit trending, PV deviation trending, PV CAPAs, trending and agreed upon metrics to ensure Quality oversight.
• Ensure the updates needed for audit related information to the PSMF and participate actively to the QPPV extended meeting.
• Contribute to the GVP audit strategy according to SOPs.
• Prepare GVP Audit annual plans according to SOPs, ensuring the risk assessment and prioritization of the GVP Audits are performed in collaboration with GPV organization and with GVP Audit program owner
• Authoring GVP QA related processes, review and approve the PV related SOPs (or SOPs from other RDMA and Quality areas with implicit or interfaced PV activities eg Medical information, regulatory, medical affairs, compassionate use)
• Ensure active contribution in the cross functional team with procurement and business owners for GVP requirements and documented QA qualification of GVP service providers and review PV provision in contracts/Quality agreements, as applicable
• QA representative during PV inspections and partner audits and promote the Inspection Readiness framework and continuously quality mindset across Sobi.

Qualifications

• University degree in Life Sciences or related discipline.
• At least 5 year experience from the pharmaceutical industry with GVP responsibilities, and audit management and/or Quality Assurance experience
• Excellent knowhow of the EU/US/RoW regulations within GVP as well as Quality assurance activities principles and know-how
• Documented education/experience in QA systems and preferably auditing
• Structured approach with strong focus on results and highly detai-oriented orientation
• Strong interpersonal skills with communicative and flexible attitude
• Proactive and collaborative mindset with a strong multi-tasking abilities and a high resilience and adaptative skills
• You should live up to our core values: Ambition,Ownership, Urgency, Partnership and Care