Global Senior Pharmacovigilance QA Manager

About Idorsia Pharmaceuticals Ltd

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in‑house development pipeline; and a specialized drug discovery engine focused on small‑molecule drugs that can change the treatment paradigm for many patients.

We are looking for a Global Pharmacovigilance QA Manager to join our team!

The Global Pharmacovigilance QA is a strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations. He/She independently leads and manages the planning, conduct and reporting of PV compliance audit programs and ensures a standardized approach is implemented and maintained across all affiliate sites for PV and the related Quality System.

Experience in Commercial GDP QA /Supply Chain QA is an advantage.

• Act as a primary contact with internal stakeholders (affiliate, corporate functions), establishing and maintaining effective relationships, driving collaboration and providing expert-level PV knowledge and guidance on complex topics and issues. Take an active role in, and lead key project initiatives across the organisation, and independently provide strategic advice to internal or external stakeholders to drive policy and decision making.
• Act as local PV QA Manager appointed to affiliate sites and ensure implementation of a standardized PV system, consistent with HQ procedures. Support Idorsia affiliate sites as applicable in the establishment, implementation and management of their local PV system.
• Maintain, improve and assure execution of a risk‑based, global PV QA audit program covering internal and external audits to verify adherence to the PV system, as defined in FDA and EMA Regulations.
• Perform PV QA audits of vendors across affiliate sites as applicable and of affiliates and maintain oversight of QA consultants appointed to perform PV audits on behalf of the company.
• Ensure audit results are formally and consistently tracked, recorded, reported, trended.
• Ensure corrective/preventive actions have been identified, documented and are effective.
• Cooperate with the EU QPPV and national Affiliate Safety Managers (ASM) and take responsibility for interaction with the Competent Authorities, and for the preparation, conduct and follow up of inspections performed at Idorsia sites as applicable. Represent PV QA at local and/or global inspections.
• Responsible for escalation of significant PV compliance issues to senior management.
• Provide in a timely manner the necessary QA output to the EU QPPV (and national ASMs, if applicable) to establish and maintain the PSMF Quality section and audit related PSMF annexes.
• Ensure inspection readiness of vendors conducting PV activities through metric review, vendor audit findings, CAPA generation and review, and training.
• Ensure procedures for archiving of records at affiliate sites are in line with Idorsia policies.
• Review the suitability of procedures for CAPA and deviation management, root cause analysis and perform QA effectiveness checks at HQ and at affiliate sites.
• Ensure appropriate and timely management of non‑conformances related to relevant GxP: deviations, change controls, internal and external CAPAs, Quality Events.
• Manage Affiliate documentation and training records within Idorsia Quality System, in collaboration with HQ QA and affiliate. Review and approve local (GxP related) standard documentation and develop local Quality related procedures as required, in accordance with HQ QA principles and processes. Monitor training compliance.
• Plan and execute periodic exchange of information across affiliate sites regarding PV system topics.
• Maintain high level of knowledge of current global pharmacovigilance regulations,…