Senior QA Manager, Pharmacovigilance

Ipsen Innovation (SAS); Boulogne; Hybride; EUR 60 000 - 100 000; Plein temps

Résumé du poste

An established industry player is seeking a Senior QA Manager in Pharmacovigilance to lead quality management efforts. This role involves ensuring compliance with regulatory standards, managing audits, and fostering a culture of continuous improvement. The ideal candidate will have extensive experience in pharmacovigilance and quality systems, along with strong communication skills. Join a passionate team dedicated to making a difference in patients' lives and contribute to impactful projects in a collaborative environment.

Qualifications

• Extensive experience in pharmacovigilance and quality management.
• Strong understanding of GVP regulatory requirements.

Responsabilités

• Manage PV quality system to ensure regulatory compliance.
• Coordinate external audits and inspections for pharmacovigilance.

Connaissances

Pharmacovigilance

Quality Management Systems

Regulatory Compliance

Communication Skills

Cross-functional Working

Formation

Bachelor's Degree in Life Sciences

Master's Degree in Pharmacology

Description du poste

Senior QA Manager, Pharmacovigilance page is loaded

Senior QA Manager, Pharmacovigilance

Apply locations Boulogne time type Full time posted on Posted 15 Days Ago job requisition id R-18773

Title:

Senior QA Manager, Pharmacovigilance

Company:

Ipsen Innovation (SAS)

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram .

Job Description:

The Senior QA Manager, Pharmacovigilance (PV), is responsible for maintaining, developing, and monitoring the PV quality system to ensure compliance with regulatory requirements and internal standards. This role acts as the primary point of contact for Global Patient Safety (GPS)/PV functions regarding PV quality system management and supports cross-functional processes impacting PV quality system, including regulatory affairs, clinical and medical affairs, affiliates, etc. The position also contributes to promoting a Quality culture of continuous improvement.

The ideal candidate should have a deep knowledge of GVP regulatory requirements and industry standards. Additionally, they need considerable experience in pharmacovigilance, expertise in developing and executing Quality Management Systems, and familiarity with health authorities inspections and audits tied to pharmacovigilance.

Main responsibilities:

Quality Documents Management

• Acts as QA representative for GPS regarding Quality Documents Management.

• Ensures the maintenance of PV Quality Documents System by supporting their creation and update as per quality documents life cycle management.

PSMF Maintenance

• Manages timely update of the PSMF body and annexes listing quality documents, deviations audits findings, and CAPA updates

Deviation and CAPA Management

• Accountable for overall oversight on deviations and CAPA Plans related to or impacting the Ipsen PV system.

• Ensures continuous overview and monitoring of CAPA implementation by tracking progress, providing reporting, and escalating as needed

• Manages the QA review of PV deviations and consistency of CAPA Plans, across the organization at global and local level

Audits and Inspections

• Coordinates the preparation and hosting of pharmacovigilance external audits and inspections.

• Supports any pre-audit/pre-inspection request management.

• Acts as primary contact for requests PV Quality Management System and provides responses when observations are related to the PV Quality System

• Coordinates post- audit and post-inspection activities

Additional duties

• Implements and tracks compliance KPIs related to QMS.

• Provides quality updates for EU QPPV oversight.

• Develops and delivers PV QMS training.

• Supports affiliates with guidances on PV QMS.

• Support periodic review of PV QMS

• Acts as the Subject Matter Expert within Global Quality and contributes to Quality objectives

To be considered for this role, you will have:

• Extensive experience in pharmacovigilance, including expertise in pharmacovigilance quality management and PV compliance management.

• Cross-functional working skills

• Good communication skills: oral-written

• Result oriented – drives execution and accountability

• Fosters team work

• Demonstrates agility and flexibility

• Fluent in English

If you think this sounds like the right opportunity for you then don’t wait, apply today and become part of the team improving the lives of patients globally!

#LI-Hybrid

Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.

Why work here?

At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients’ lives. We invest in our employees to support life-changing projects that create positive impact for patients and society.

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