R&D and Pharmacovigilance Compliance Lead (90431)

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: R&D and Pharmacovigilance Compliance Lead Bulle Switzerland.

About the role

As a member of the UCB Quality organization the R&D and PV Compliance Lead ensures compliance with evolving laws and regulations to protect patients and uphold UCBs reputation.

The Compliance Lead supports stakeholders in investigating significant events emphasizing quality by design right-first-time practices and inspection readiness during all development phases of UCB compounds globally. You will provide quality support foster a culture of data-driven oversight and lead cross-functional quality improvement initiatives.

You will work with

As a member of the UCB Quality organization the R&D and PV Compliance Lead will collaborate with a diverse range of stakeholders. This includes internal teams such as R&D PV Quality and other business units as well as external partners like industry experts and third-party vendors. By working closely with these groups the Compliance Lead ensures that quality standards are met and maintained throughout the development and post-marketing phases of UCB compounds. This collaboration is essential for driving quality by design ensuring right-first-time practices and maintaining inspection readiness ultimately protecting patients and preserving UCBs reputation.

What you will do

Pro-actively identify opportunities to de-risks at a system/vendor/partner level across compounds and development phases

Plan and execute quality activities independently to ensure subject safety and data integrity complying with regulations procedures and contractual agreements.

Partner or Lead compliance investigations and ensure timely closure of corrective and preventive actions from assigned deviations audits and/or change control processes impacting regulatory processes.

Escalate issues early and ensure effective risk-based resolution are in place.

Leverage internal stakeholders and subject matter experts network to develop appropriate action plans decisions and ensure efficient actions are taken to ensure compliance.

Monitor the performance of (quality) systems and solutions and the quality of data to support oversight on critical to quality indicators and key decisions

Conduct analytics and qualitative assessments to identify trends and deliver insights.

Monitor the quality performance of UCB processes strategic vendors and partners.

Review and coordinate the output of business trends from deviations audits/inspections and risk analyses and provide senior management and relevant stakeholders with a summary and analyses of comparative risks and outcomes across multiple assets.

Act as Quality Improvement Initiative Lead

Propose and lead Quality Improvement Initiatives based on identified signals/trends/risks relating to systems/processes and vendors to pro-actively ensure quality and compliance including the promotion of quality throughout the products lifecycle end-to-end. end-to-end quality.

Support initiatives to increase the quality culture.

As Regulatory Compliance Quality Advisor

Review and implement updates to GxP legislations define best practices and assess the impact on procedures systems and contractual arrangements

Provide QA input during the creation and revision of UCB procedural documents to ensure GLP GCP and GVP compliance or procedural documents under regulatory accountability (depending on the assignment).

Represent R&D and PV Quality at interdepartmental and project team meetings as assigned.

Deliver presentations to peers senior management and industry audiences as assigned.

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

Bachelors Degree required; Masters Degree preferred in Life Sciences Related Field.

Preferable 10 years of experience working in the (bio)pharmaceutical industry preferred with a minimum of 5 years in the research clinical development or Pharmacovigilance domain.

Proficient in research/GLP GCP and/or GVP regulations and applicable regulatory framework.

Ability to translate regulatory and quality expectations into operations based on knowledge of quality principles

Expertise in managing non-compliance root-cause investigations and robust CAPA development in at least one of the GxPs.

Experience in leading transversal quality/process optimization projects background in continuous improvement methodologies.

Ability to analyse data perform trend analysis and lead meaningful discussions with business management for meeting compliance requirements.

Experience working with data analysis tools and notion of applying AI and Machine Learning in pharmaceutical industry.

Ability to drive collaboration and engagement across the stakeholder network motivating others to achieve results

Skilled in influencing others within a global matrix organization and driving informed decision making.

Manages quality and compliance issues with diligence rigor transparency and timeliness

Proficient in presenting complex projects and issues clearly and succinctly

Excellent planning organizational presentation training communication and interpersonal skills.

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 equitable 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 and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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.