MANAGER INSPECTION & AUDIT READINESS

About the Role About the role.
Manager Inspection & Audit Readiness, Homebased Spain, or UK or alternatively hybrid onsite in Barcelona, #LI-Remote.
The Manager, Inspection and Audit Readiness is responsible for ensuring that the organization is fully prepared for external inspections and audits through the organization's compliance with regulations and standards.
You will also be responsible for global support in the management of new and changed pharmacovigilance (PV) regulatory requirements, and for the conduct of self-inspections.
The role is based remotely in either Spain or the UK or alternatively hybrid onsite in Barcelona where the Global group is located.
The team currently support around 7 global pharmacovigilance inspections annually and more than 30 audits, so it is essential you have a quality mindset and a breadth of pharmacovigilance systems experience.
Key Responsibilities.
• Support for the management of Good Pharmacovigilance Practices (GVP) inspections and inspections readiness in the central sites and provide collaborative support for readiness at company sites.
• Maintenance of current information on pharmacovigilance inspections, inspection readiness including quality and consistency measures and collaboration and expert support for the operational teams with inspection readiness activities.
• Support the management and oversight of implementation of new Pharmacovigilance regulatory initiatives, requirements and guidelines through facilitative support to global impact assessment and action planning conducted on all changes to regulatory requirements and guidelines.
• Collaborate on process verification for centralised collation of regulatory knowledge for defined pharmacovigilance deliverables to support reliable metric generation.
• Support the identification and endorsement for global PV self–inspections targets.
• Responsible for the conduct of the global PV self-inspections in collaboration with Contract Manufacturers & Patient Safety QA.
• Support oversight of audits and audit readiness in the central sites, through preparation readiness of subject matter experts and response development and audit tool management.
Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements Essential Requirements.
• Life science Degree (or equivalent).
• Good knowledge/fluency in English.
• At least 5 years’ experience mainly in a Clinical Safety Department or closely related areas e.
.
Clinical Development.
• Must have knowledge of global regulations for Pharmacovigilance.
• Global vision of Pharmacovigilance.
• Audit preparation & outcome measurement together with Self-Inspection preparation & outcome measurement experience.
• Communication and influencing skills, and the ability to effectively collaborate with various stakeholders.
• Excellent analytical and problem-solving skills to identify compliance gaps and support effective solutions.
• Attention to detail and ability to work under pressure to meet tight deadlines.
Desirable Requirements.
• Global experience is desirable but hands on local experience will be considered.
• Knowledge of other languages with Spanish being possibly beneficial.