Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.
We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.
The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.
We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.
The Audit and Inspection Senior Manager will coordinate all activities around PV audits and inspections. You will:
- Lead the preparation to regulatory PV inspections and quality PV audits, to secure readiness at any times.
- Lead the GPS activities, before, during the conduct of audits and inspections and for the development and follow-up of related CAPAs.
- Establish, maintain, and update the GPS procedures to document the GPS process for audit and inspection.
- Develop any relevant tools to help the GPS compliance team, GPS department, local PV representatives and any interfaced stakeholders to be more efficient at the time of audit and inspection.
Main Responsibilities:
PV Global Internal/External Audit and Inspection preparation
- Support in collaboration with Global R&D PV quality team and GPS Compliance team the preparation of audits/inspections including inspection readiness activities, review of Subject Matter Experts (SMEs) presentations, scribe training
PV Global Internal/External Audit and Inspection conduct
- Lead or co-lead with the Head of GPS Compliance the Back Office of audit/inspection
PV Global Audit and Inspection follow-up
- Coordinate the response and CAPA plan preparation to audit/inspection reports with GPS SMEs and assist SMEs as appropriate to ensure robustness of CAPA plan.
Local PV Audits and Inspection
- Provide support to Affiliates in collaboration with Global Teams for the preparation, conduct and follow-up of local PV audits or inspections as relevant.
Audits of partners by Global Quality Audit (GQA)
- Act as the main GPS contact point for GQA if a GPS input is needed in the scope of a partner audit
Quality documents and regulatory intelligence
- Develop, maintain and update a procedure to document the process for audit and inspection and to describe the roles and responsibilities of the GPS compliance team vs PV quality team.
PSMF
- Contribute to the PSMF updates within GPS Compliance Team
EHS responsibilities
In order to be considered for this role you must have:
- Extensive experience within Drug Safety, Clinical Development and/or Pharmacovigilance
- Expertise in safety data collection, evaluation, reporting, scientific interpretation and communication
- Advanced understanding of quality and pharmaceutical regulatory compliance
- Demonstrated knowledge of GxP requirements (GVP/ GCP/GMP)
- Thorough and technical understanding of PV systems, processes and databases
- Fluency in English.
If you feel that this could be the right next step for you, we would be delighted to engage with your application.
