R&D and Pharmacovigilance Compliance Lead
Join to apply for the R&D and Pharmacovigilance Compliance Lead role at UCB.
R&D and Pharmacovigilance Compliance Lead
2 days ago Be among the first 25 applicants.
Join to apply for the R&D and Pharmacovigilance Compliance Lead role at UCB.
To strengthen our R&D and Pharmacovigilance Quality department, we are looking for a talented professional 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 UCB’s 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 internal teams such as R&D, PV Quality, and other business units, as well as external partners like industry experts and third-party vendors. This collaboration ensures that quality standards are met and maintained throughout the development and post-marketing phases of UCB compounds, driving quality by design, ensuring right-first-time practices, and maintaining inspection readiness to protect patients and UCB’s reputation.
What You Will Do
Proactively identify opportunities to de-risk at system/vendor/partner levels 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 with or lead compliance investigations, ensuring timely closure of corrective and preventive actions from deviations, audits, and change control processes impacting regulatory processes.
* Escalate issues early and ensure effective risk-based resolutions are in place.
* Leverage internal stakeholders and subject matter experts to develop action plans, make decisions, and ensure compliance.
Monitor the performance of quality systems, solutions, and data quality to support oversight on critical quality indicators and key decisions
* Conduct analytics and assessments to identify trends and deliver insights.
* Monitor the quality performance of UCB processes, vendors, and partners.
* Review and coordinate business trend outputs from deviations, audits/inspections, and risk analyses, providing summaries and analyses of risks and outcomes across assets to senior management and stakeholders.
Act as Quality Improvement Initiative Lead
* Propose and lead Quality Improvement Initiatives based on signals, trends, and risks related to systems, processes, and vendors to proactively ensure quality and compliance throughout the product lifecycle.
* Support initiatives to foster a quality culture.
As Regulatory Compliance Quality Advisor
* Review and implement updates to GxP legislations, define best practices, and assess impacts on procedures, systems, and contracts.
* Provide QA input during the creation and revision of UCB procedural documents to ensure GLP, GCP, and GVP compliance.
* Represent R&D and PV Quality in interdepartmental and project meetings as assigned.
* Deliver presentations to peers, senior management, and industry audiences as needed.
Qualifications and Skills
* Bachelor's Degree in Life Sciences or related field required; Master’s preferred.
* Preferably 10+ years of experience in the (bio)pharmaceutical industry, with at least 5 years in research, clinical development, or Pharmacovigilance.
* Proficient in research/GLP, GCP, and GVP regulations and frameworks.
* Ability to translate regulatory and quality expectations into operational practices.
* Expertise in managing non-compliance, root-cause investigations, and CAPA development within GxPs.
* Experience leading cross-functional quality and process optimization projects, with a background in continuous improvement methodologies.
* Strong data analysis skills, including trend analysis and stakeholder communication.
* Experience with data analysis tools and applying AI/ML in pharma.
* Excellent collaboration, influencing, and decision-making skills within a global matrix organization.
* Strong organizational, presentation, training, and interpersonal skills.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If so, we want to hear from you!
About Us
UCB is a global biopharmaceutical company focusing on neurology and immunology, with about 8,500 employees worldwide, driven by science and inspired by patients.
Why work with us?
We create value through innovation, collaboration, and a human-centered approach. Our culture is inclusive, respectful, and supportive, offering opportunities for growth and career development. We are committed to diversity and inclusion and are an Equal Opportunity Employer. For accommodations during the application process, contact us at EMEA-Reasonable_Accommodation@ucb.com.
Additional Information
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr