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Vendor Quality Lead

Il y a 3 mois

Brainel'Alleud, Wallonie, Belgique UCB Temps plein

Make your mark for patients

To strengthen our Quality Assurance – Early & Clinical Department Quality department, we are looking for a skilled professional to fill the position of a Vendor Quality Lead based in Braine l'Alleud-Belgium.

About the role

This role will guide and provide comprehensive QA expertise to steer strategic and operational Quality Assurance efforts with global vendors involved in GLP, GCP and GVP activities related to UCB Sponsor/MAH obligations.

You will work with

This position entails close collaboration with UCB QA management, Candidate/Asset/Brand Quality Leads focused on GLP, GCP and GVP compliance, GMP/GDP VQLs for interface vendors, Corporate Process Owners, internal UCB teams delegating activities to vendors, as well as Procurement and Legal departments.

What you will do

  • Participate in assessing and qualifying vendors, identifying and communicating risks based on business, GLP, GCP, GVP operational and quality expertise to relevant internal UCB functions
  • Ensure and maintain quality agreements with assigned vendors, performing periodic reviews and updates in collaboration with product quality leads, compliance and inspection management leads in ECDQ and the vendors
  • Act as the central QA contact for investigations, deviations and audit observations associated with assigned vendors. Conduct QA reviews of deviation notifications and coordinate the collection of supportive information from stakeholders if required
  • Ensure processes are compliant, quality is built in by design, relevant documents are in place and training is completed prior to executing GLP, GCP and GVP activities.
  • Manage and monitor KPIs for key operational QA activities and outsourced services using defined tracking tools, quality agreements and UCB functional SOPs, with frequency determined by service criticality
  • Organize or participate in recurrent vendor meetings as a quality representative, presenting and following up on issues and action plans, driving vendor quality performance and providing regular updates to quality management
  • Collaborate with UCB functional areas, procurement, and global quality leads to determine root causes of issues, potentially leading to additional GCP, GVP and GLP compliance investigations
  • Review relevant regulatory documents, including data managed or delivered by assigned vendors
  • Oversee UCB audits and Health Authority inspections related to vendors, track audit observations and follow up on CAPA plan implementation
  • Work in accordance with UCB HSE and Corporate policy requirements, promoting personal training and development to meet business needs and professional career growth
  • Act as a Best Practice ambassador and lead best practice initiatives as assigned

Interested? For this position you'll need the following education, experience and skills

  • Master's degree
  • Proficient in the English language
  • Extensive knowledge of the global pharmaceutical industry, including the interpretation and practical application of relevant regulations. Strong background in the pharmaceutical industry from both business and technical perspectives, with a focus on GLP/GCP and GVP.
  • Ability to operate independently in most situations and handle complex or challenging scenarios, with actions likely impacting multiple departments
  • Strong auditing capabilities and skills
  • Proficiency in interacting with and influencing senior internal and external personnel on various project and product-related matters
  • Excellent social, verbal and written communication skills at all levels, particularly with senior management
  • Ability to generate team commitment, encourage and promote new ideas and act as a role model in driving projects and the company vision
  • Skilled in coaching, training and mentoring colleagues, delivering training within the area of expertise and assisting in the development of top talent
  • Experience operating across cultures in a multi-cultural environment
  • Strong skills in root cause analysis and risk management/assessment

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 '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 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't 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 that's 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 on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.