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Let's push the boundaries together and make the most of your talents!

Vendor Quality Lead Biologics QualityOps

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  66390

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

Vendor Quality Lead

Quality Assurance department

Braine l’Alleud, Belgium

 

Help us transform patients’ lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe 
disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.

Will you join us in our pioneering adventure?

 

To strengthen our Global Quality Assurance department, based in Braine l’Alleud, Belgium, we are looking to fill the position of: Vendor Quality Lead.

 

As a UCB Vendor Quality Lead you like to work in an environment where you can:

  • Drive operational Quality Assurance activities at key vendors (in the GMP environment) for late stage development/commercial biological molecules (monoclonal antibodies) and specific QA support/consultancy for projects on biological molecules.

This will be archived through close partnering with QA management at vendor sites and collaboration with UCB Supply & Technical Solutions and other UCB teams.

 

As a UCB Vendor Quality Lead, you will contribute by:

 

Vendor management:

Provide expert advice, support and management for technical operational QA and general QA matters for specific vendors involved, on behalf of UCB, in the manufacture and/or testing of late stage development and Commercial Biologics (monoclonal antibodies). Specifically focus on the following:

  • Negotiating and setting Quality Agreements
  • Monitoring and trending vendor performance
  • Performing review and ensuring tracking of batch records, deviation reports, change control reports
  • Facilitating investigations and resolution of issues relating to the disposition of the batches
  • Overseeing/tracking change management
  • Tracking CAPA events and closure
  • Performing focused assessments/audits
  • Performing reviews of GMP documents
  • Providing on-site presence at vendor
  • Ensuring systems alignment between vendor and UCB
  • Facilitatinging quality improvement activities at vendor and UCB systems
  • Supporting risk register for the vendor and following up on mitigation activities
  • Reviewing and assessing Product Quality Review report for the vendor (PQR)
  • Reviewing Complaint Investigation reports form the vendor
     

Assist with regulatory and customer inspections at Vendors. Specifically focus on:

  • Inspection preparation
  • Support during inspection
  • Support post inspection observation closure

 

Project support:

Provide expert advice and support on operational and general QA activities for projects part of the Biologics portfolio (Process Improvement, Technology Transfers, Process validation and related regulatory submissions):

  • Agree with team activities required for implementation
  • Change controls – assessment in TrackWise, attend change control committee, track closure of actions to submission approval
  • Liaison with Regulatory Affairs
  • Review and approval protocols and reports for validation studies, Technology Transfers and Stability studies
  • Review and approve submission and response
  • UCB documentation review and approval
  • Deviation review and approval during validation and technology transfer
  • Work closely with Technical Operations teams to ensure that all QA services are provided in an effective and efficient way.

 

General GMP:

  • Maintain Quality System elements associated with the GMP activities in a compliant manner
  • Maintain key performance indicators (metrics) for key operational QA activities and services associated with the Commercial Cimzia or other biological molecules activities
  • Maintain GMP compliance and inspection/audit readiness at all times. Support Head of Commercial QA in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
  • Drive/support projects related to quality system improvement

 

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

  • Master’s degree with minimum of 5 years working in the pharmaceutical biological industry in a GMP operational quality position
  • In-depth knowledge and understanding of relevant areas of pharmaceutical development and/or commercial requirements, in particular related to manufacturing activities of biological products (monoclonal antibodies)
  • Experience interaction with third party organizations with respect to QA systems and regulatory inspection preparedness
  • GMP auditing expertise
  • Management and leadership skills:
  • Must be able to act under minimal supervision on routine task and handle complex/difficult situations with supervision. Output form actions will most likely impact activities across several departments
  • Must be able to effectively interact with and influence internal and external personnel on many aspects of projects and product related matters
  • Must possess excellent interpersonal, verbal, and written communication skills in English at all levels internally and externally
  • Represent UCB in front of critical vendors or regulatory inspectors
  • Mobilize relevant colleagues, business partners and other stakeholders when facing obstacles
  • Demonstrate an ability to influence different audiences
  • Takes initiatives in sharing best practice across the organization
  • From a behavioral perspective, generate commitment from within teams, encourage and support new ideas and act as a role model for others in driving the department/company vision.
  • Delivering solutions
  • Must have the ability to independently analyze data and information to draw conclusions and make effective decisions
  • Must have ability to identify risks and propose corrective actions within areas of expertise. Also, demonstrate imitative and ability to help others solve problems in a creative and practical way
  • Must be able to coach staff and colleagues through effective problem solving to ensure the best resolution is obtained
  • Must be able to develop innovative solutions through judgment and reasoning leverage form extensive quality experience

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

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