Impact Quality Lead

Make your mark for patients

We are looking for an Impact Quality Lead responsible for implementing and maintaining a balanced proactive global approach to pharmacovigilance (PV) compliance to join us in our R&D and Pharmacovigilance Quality team based in our UCB Inc. office in Atlanta Georgia USA.

About the role

The Impact Quality Lead falls with the Impact Quality team within R&D and Pharmacovigilance Quality. This position is a global role responsible for ensuring pharmacovigilance (PV) activities are conducted in accordance with applicable global regulatory requirements guidelines polices procedures and industry best practice. The ideal candidate for this position should possess GVP experience in the pharmaceutical industry and have work experience supporting pharmacovigilance quality assurance along with a demonstrated track record of success in providing quality oversight to critical PV process such as case processing aggregate reports quality assurance systems PV vendors audits Safety Data Exchange Agreements etc. A candidate that also possesses GCP experience would be ideal.

Who youll work with

The role 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 youll do

The Impact Quality Lead GVP is responsible for providing Quality oversight to the UCB Pharmacovigilance System and the UCB Pharmacovigilance Quality Management System. Specific tasks include:

• 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).
• 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 Quality Management Support - The Impact Quality Lead GVP develops and executes a comprehensive and efficient Quality Assurance strategy for the critical PV processes aligning with UCB SOPs and regulatory requirements.
• The role monitors compliance with global regulatory requirements by ensuring the implementation of appropriate SOPs processes metrics and monitoring of performance and compliance and training at a global level.

Interested For this role were looking for the following education experience and skills

Required Qualifications:

• Bachelors degree in Life Sciences Masters degree is a plus with 8 10 years of experience in drug safety/pharmacovigilance quality assurance or compliance within the pharmaceutical or biotech industry.
• Proficiency in internal auditing partner auditing risk assessments compliance monitoring and inspection management activities preferred.
• Knowledge of GVP and GCP and applicable regulatory framework.

Preferred Qualifications:

• Ability to proactively identify assess and identify solutions to mitigate potential risks to the pharmacovigilance system.
• Ability to lead medium to high complexity projects.
• Excellent verbal and written communications skills in English.

*This positions reasonably anticipated base salary range is $124000-$162800 annually. The actual salary offered will take into account internal equity and may also vary depending on the candidates geographic region job-related knowledge skills and experience among other
#TeamUCB

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 around 8500 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.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal state or local law.

UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment your employment with UCB or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws orders and regulations.

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