Impact Quality Lead (Switzerland)

Make your mark for patients

To strengthen our R&D and Pharmacovigilance Quality department we are looking for a talented profile to fill the position of:Impact Quality Lead Bulle Switzerland

About the role

As Impact Quality Lead you will be part of the with the Impact Quality team within RDPVQ. The Impact Quality Lead is a global role responsible for implementing and maintaining a balanced proactive global approach to pharmacovigilance (PV) compliance. This position is primarily responsible for ensuring PV activities are conducted in accordance with applicable global regulatory requirements guidelines polices procedures and industry best practice.

You will work with

You will collaborate closely with UCB cross-functional teams supporting pharmacovigilance activities including the Global Pharmacovigilance organization Affiliate Offices Clinical Operations Regulatory Affairs Commercial teams etc. Key responsibilities include overseeing the pharmacovigilance system and pharmacovigilance quality system and providing oversight to Phase IVs studies and post-marketing commitments.

What you will do

Pharmacovigilance System Support

• Provides expert guidance on Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) global regulatory expectations (FDA EMA ICH) and industry best practices to ensure compliance and operational excellence.
• Provides support to Phase IV study types (i.e. Non-Interventional Studies Compassionate Use Surveys Managed Access Programs Named Patient Programs Patient Centered Outcomes Research Registries).
• Provide oversight to UCB patient centric initiatives (including patient support programs market research programs digital initiatives IIS PASS medical information collaboration studies).
• Reviews processes for data integrity and quality during signal detection and risk management activities.
• Supports validation and control of PV electronic systems.
• Ensures PV outputs are compliant including individual case safety reports (ICSRs) development safety update report (DSURs) Risk Management Plan (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) etc.).

PV SOP Management and Training

• Provide guidance and support in developing and revising pharmacovigilance SOPs work instructions and training materials to ensure regulatory alignment and best practices.
• Stay updated on changes in pharmacovigilance regulations guidelines and industry trends to ensure ongoing compliance and proactively address emerging requirements.
• Ensures targeted training programs on GVP regulatory expectations and quality principles are delivered

Partner/Vendor Oversight

• Provides critical oversight of PV partners/vendors to ensure efficient consistent and compliant pharmacovigilance activities. Monitors contract compliance quality and timeliness of deliverables.
• Interacts with clinical and pharmacovigilance vendors to ensure compliance with GCPs and GVPs and relevant country regulations.

Audits and Inspections

• Hosting of PV audits and inspections.
• Supports audit and inspection findings by developing and implementing effective remediation plans.

Compliance Monitoring

• Leads mitigation efforts with key stakeholders (PV Safety Regulatory and Clinical teams) to ensure alignment on quality standards and compliance requirements.
• Monitors regulatory submissions related to on-time delivery of ICSRs (to global Health Authorities partners including SUSAR and SAE communication to Ethic Committees and investigators as applicable) as well as the on-time submission of aggregate reports.
• Review and monitor vendor compliance through various reports and oversight activities including tracking KPIs metrics and quality control checks.
• Participating in Pharmacovigilance specific Governance meetings.
• Identifies tracks trends and communicates PV compliance activities to senior management.

Deviation Management and Risk Management

• Initiates deviations from discovery ensures management and root cause analysis and tracks CAPA implementation and evaluates effectiveness.
• Establishes processes to identify assess and mitigate risks related to pharmacovigilance activities.
• Collaborate with cross-functional teams to address quality and compliance-related issues and drive process improvement initiatives.

Interested For this position youll need the following education experience and skills

• Bachelors degree preferably in Science or Engineering.
• 12 years of experience in GVP Quality Assurance GVP Auditing Pharmacovigilance or a related field within the pharmaceutical biotechnology or healthcare industries.
• Fluent English communication (oral and written); any additional languages are a plus.
• Proven experience in supporting/leading GVP audits regulatory inspections and providing GVP quality management system support.
• Strong global knowledge and understanding of local and international regulations applicable to the conduct of clinical trials and pharmacovigilance operations (GVPs ICH guidelines FDA MHRA).
• Strong analytical problem-solving communication and decision-making skills.
• Strong commitment to ethical standards
• Develops trustful relationships with internal and external stakeholders to accelerate business achievements.
• Takes initiatives and works towards delivering results. Takes courageous decisions and balanced risks to create value for patients and UCB.
• Ability to anticipate influence & apply GVP regulations to ensure effective interpretations that support decision-making on current and future solutions to improve patients lives.
• Ability to independently and critically evaluate quality management systems and quality operations in support of Quality culture and operational output balancing weaknesses against requirements and expectations.

Are you ready to go beyond to create value and make your mark for patients If this sounds like you then we would love to hear from you!

About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.

At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Employment Type : Full Time
Experience: years
Vacancy: 1