Global Pharmacovigilance & Clinical Quality Lead

Opella; Neuilly-sur-Seine; Sur place; EUR 80 000 - 110 000; Plein temps

Résumé du poste

A leading pharmaceutical company in Neuilly-sur-Seine seeks a Global Pharmacovigilance & Clinical Quality Lead. This role requires 10-15 years of experience in Clinical and PV Quality, with a focus on leading quality management in clinical trials. The ideal candidate will collaborate with various teams, ensuring compliance and high-quality standards throughout our clinical operations. Proficiency in English is necessary, while knowledge of French is highly advantageous.

Qualifications

• 10-15 years’ experience in Clinical and/or PV Quality (GMP and GCP, GVP).
• English is mandatory; French is a very big advantage.

Responsabilités

• Support Global Safety & Clinical teams, design Quality systems.
• Lead Vendors quality management and reviews.
• Manage escalated risks and provide support to RQN.
• Review & risk assessment for audits and inspections.

Connaissances

client oriented

outcome obsessed

good listening skills

change agent

decision maker

business partner

assertiveness

networking capability

team player

Formation

Master’s degree in chemistry, Biochemistry, Pharmacy, or Engineering

Outils

quality systems (GMP annex 13 and GCP)

Description du poste

About The Job

Opella Global Quality is a team of highly motivated people to build state-of-the-art quality with an E2E approach across Opella business and ensure best quality and compliance for our patient safety.

Within Global Quality, the Global Science Quality Team is the gatekeeper of quality for all regulated activities in Science (Development & Regulatory, Pharmacovigilance, Medical/Clinical and Innovation projects). We lead and manage the implementation of the Quality management systems within Science organisation to ensure activities and data are managed in compliance with the Global Quality standards and applicable regulatory requirements.

Main Responsibilities

The purpose of the Global Pharmacovigilance & Clinical Quality Lead is to support the Global Safety & Clinical teams, design the Quality systems and oversee implementation to ensure that clinical trials and Pharmacovigilance activities are conducted and data are generated, documented (recorded), and reported in compliance with GVP, GCP and GMP requirements.

Design the Global Quality Systems Operations for Pharmacovigilance & Clinical regulated activities

• Lead Vendors quality management and vendors Quality reviews.
• Design and implement Vendors Quality management processes in collaboration with BPO and work closely with the Audit & Inspection team to design Vendors Qualification strategy.

Event, CAPA and Change Control

• Manage escalated risk and provide support to RQN.
• Assess Change Control requests.

Audit & inspection operations

• Review & risk assessment: work closely with the Audit & Inspection team to set up audit plans and contribute to Global/Local audit & inspection, including coordination of business preparation.
• Coordinate and manage audit & inspection preparation responses and CAPA definition.

Quality Performance Management

• Lead annual PV & Clinical Quality reviews.
• Consolidate KPI reports and perform trend analysis with action plan.

Quality Document & training

• Work closely with the Global Science QD & Training Head to ensure the robustness and compliance of the QD system and training management system in PV & Clinical.

Clinical Product

• Work with Risk management team to design recall procedure and perform mock recall.

As the Quality Business Partner for the Global Safety & Clinical teams

Represent Quality in key governance bodies/committees or projects or in front of business. Be GCP/GMP and GVP expert providing Quality input and supporting the Clinical and Pharmacovigilance teams. Build strong partnership with Pharmacovigilance, Clinical leaders, leadership team and EUQQPV (and contribute to PSMF update). Escalate quality issue as appropriate to function leaders and direct manager. Develop and promote Quality culture.

As a member of the Science Quality Operations Teams

• Collaborate with other Science Quality Leaders to standardize and continuously improve operational processes.
• Collaborate closely with the Clinical and PV Quality Operations Managers to ensure timely execution, full compliance, and alignment with Quality Strategy.
• Lead transversal Quality continuous improvement initiatives.
• Perform additional activities to support the team - Back up to direct manager as needed.

About You

• Experience: 10-15 years’ experience in Clinical and/or PV Quality (GMP and GCP, GVP)
• Soft skills: client oriented, outcome obsessed, good listening skills, change agent, decision maker, business partner, assertiveness, networking capability & team player.
• Technical skills: quality systems (GMP annex 13 and GCP) – Clinical Operations & clinical supplies, pharmacovigilance.
• Education: Master’s degree in chemistry, Biochemistry, Pharmacy, Engineering (related fields).
• Languages: English is mandatory (working language), French is a very big advantage - other languages welcomed.