Regional PV QA Lead: Quality & Compliance Champion

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.; Greater London; Hybrid; GBP 64,000 - 119,000; Full time

Benefits offered by this job

Hybrid working options

Competitive benefits

14 weeks parental leave

Job summary

Novartis Pharmaceuticals UK Ltd. in London is seeking a Regional PV QA Head to lead end-to-end quality assurance vigilance activities for local and regional PV and device vigilance, ensuring compliance with regulatory requirements and Novartis procedures.

The role drives quality oversight for country operations, leads CAPA planning, and collaborates with Global PV QA to maintain inspection readiness. The ideal candidate has PV and QA leadership experience, strong knowledge of GMP/GVP

Qualifications

• Degree in Life Sciences or related scientific discipline.
• Higher degree desirable.
• Excellent written and verbal English communication skills.
• Quality/PV/clinical/regulatory affairs experience; auditing/inspection experience a plus.
• Experience in PV in a country organization with global quality support a plus.
• Ability to travel up to 20%.
• Ability to independently manage complex compliance issues with minimal supervision.
• Quality mindset and strong leadership and facilitation skills.
• Extensive knowledge of PV regulations, guidelines and policies; GCP/Part 11 awareness.
• Ability to work across diverse teams and cultures.

Responsibilities

• Drive regional and country quality oversight for implementation and maintenance of vigilance quality systems.
• Ensure regional and country quality performance aligns with PV regulations and safety requirements.
• Support the Global Research and Development Quality management cycle with deliverables from the global vigilance plan.
• Coordinate execution of the vigilance plan and report status to Global PV QA.
• Monitor indicators related to performance, compliance and quality of PV systems.
• Act as a quality champion by communicating risks and proposing mitigations.
• Communicate compliance issues to Global PS&PV and QPPV, escalate as needed.
• Lead regional quality improvement initiatives and governance activities.
• Provide expertise for vigilance quality risk assessments and CAPA planning and execution.
• Support maintenance of the global Pharmacovigilance System Master File (PSMF).
• Ensure readiness for inspections and lead inspection activities with HA where applicable.
• Review CAPA plans and approve related evidence in the QMS.
• Guide development of robust CAPAs addressing PV audit findings.
• Oversee quality issue investigations and timely escalation to management.
• Oversee self-assessment plans and review reports for PV processes.
• Identify training needs and deliver knowledge-sharing sessions.

Skills

Quality Assurance

PV Regulations

GCP/GMP Auditing

English Communication

Stakeholder Management

Travel up to 20%

Education

Bachelor's degree in Life Sciences

Higher degree desirable

Job description

Novartis Pharmaceuticals UK Ltd. in London is seeking a Regional PV QA Head to lead end-to-end quality assurance vigilance activities for local and regional PV and device vigilance, ensuring compliance with regulatory requirements and Novartis procedures.

The role drives quality oversight for country operations, leads CAPA planning, and collaborates with Global PV QA to maintain inspection readiness. The ideal candidate has PV and QA leadership experience, strong knowledge of GMP/GVP