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Early & Clinical Development Quality Lead

Il y a 4 mois

Braine L'alleud, Belgique UCB Temps plein

 

Make your mark for patients


To strengthen our Quality department, we are looking for a talented professional to fill the position of: Early & Clinical Development Quality Lead â Braine lâAlleud, Belgium

 

About the role

As part of the UCB Quality organization, the Early & Clinical Development Quality Lead (ECDQL) actively promotes quality and GLP GCP GVP compliance during the early development, clinical development and post-marketing phases of UCB compounds at a global level. Collaborating with internal teams and external stakeholders, the ECDQL plays a crucial role in ensuring quality by design and maintaining continuous inspection readiness.

 

You will work with

You will work closely with a variety of internal functions within Quality and the Business areaâs you support,  Additionally, you will engage with external partners and vendors to ensure compliance.

 

What you will do

Develop and Maintain the Quality Strategy at a Compound Level

  • Create and sustain a quality roadmap for strategic quality objectives, covering the clinical development and post-marketing phases,
  • Identify and manage risks using a risk-based approach across compounds, processes, systems, sites, and vendors
  • Ensure compliance with GxP regulations, guidance, and internal procedures while reducing complexity

Proactively Identify Opportunities to De-Risk at a Compound Level

  • Plan and execute quality activities independently to ensure subject safety and data integrity, complying with protocols and regulations
  • Lead compliance investigations and ensure timely closure of corrective and preventative actions from deviations, audits and inspections
  • Escalate issues early and ensure effective resolution or measures are in place
  • Lead or contribute to complex projects
  • Manage pre-inspection documentation, quality reviews, in collaboration with functional SMEs and global process owners.

Monitor Performance

  • Conduct analytics and qualitative assessments to identify trends
  • Monitor quality deliverables from vendors and partners, sharing updates with internal functions
  • Ensure continuous inspection readiness and integrity of the data included in regulatory dossiers
  • ead/support inspections and investigations, coordinating responses and hosting strategies

 GCP/GLP/GxP Quality Advisor Responsibilities

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

  • Provide expert advice to mitigate compliance risks or to address complex issues.
  • Deliver presentations to peers, senior management, and industry audiences


Interested? For this position youâll need the following education, experience and skills

  • Bachelor's degree in a relevant scientific or healthcare-related field
  • Minimum of 10 years in the (bio)pharmaceutical industry, with at least 5 years in research, clinical development or Pharmacovigilance.
  • Proficient in research/GLP, GCP and/or GVP regulations
  • Ability to translate regulatory and quality expectations into operations, based on knowledge of quality principles
  • Experience in GLP, GCP and/or GVP quality auditing, inspection, compliance management, and/or Medical Device regulations/operations is an asset
  • 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
  • Capable of prioritizing and focusing on critical issues using a risk-based approach
  • Manages quality and compliance issues with diligence, rigor, transparency and timeliness
  • Strong analytical skills with experience in analyzing and synthesizing complex data
  • Proficient in presenting complex projects and issues clearly and succinctly
  • Expertise in managing transversal quality optimization projects and resolving complex issues
  • Excellent planning, organizational, presentation, training, communication and interpersonal skills
  • Proficient in MS Office Suite; experience with statistical programs, SAP and Veeva is an advantage

 

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.

 

RANDATUCB


Are you ready to âgo beyondâ 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 8,500 people in all four corners of the globe, inspired by patients and driven by science. 

Why work with us? 
At UCB, we donât just complete tasks, we create value. We arenât 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 âgo beyondâ to create value for our patients, and always with a human focus, whether thatâs 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 EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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