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Global Quality Lead Evenity & Quality Systems

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  65617

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 team, based in our hub in Braine l’Alleud, Belgium, we are looking to fill the position of: Global Quality Lead Evenity and Quality Systems.

As a Global Quality Lead Evenity and Quality Systems you like to work in an environment where you can:

  • Provide leadership and QA expertise in driving strategic and operational Quality Assurance activities associated with Evenity.

This will be achieved through close partnering with QA management at vendor sites and collaboration with UCB Technical Operations and other UCB teams.

 

As a Global Quality Lead Evenity and Quality Systems you will contribute by:

Global Quality lead:

  • Having the quality oversight of the product
  • Providing QA support for all commercial initiatives and commercial activities
  • Covering the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out
  • Being the QA representative member at TST Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
  • Providing expert QA advice, support and management for technical operational QA and general QA matters for the supply chain for the product. Responsible for ensuring the routine Life Cycle Product Management activities are supported, ensures that all Lifecycle projects are supported.
  • Leading the Change Control Committee
  • Leading the Global Complaints Committee
  • Being the central point of contact for the organization for critical investigations/deviations/critical audit observations
  • If needed, guiding the team to Technical meeting if team feels issue could lead to a recall
  • If recall decided at recall committee, leading the recall execution and closure from a QA perspective
  • Ensuring all Quality Agreements are in place and take ownership of agreements between sites and Global QA for your product
  • Ensuring Annual Product Stability studies overview
  • Writing the PQR executive summary where applicable
  • Owner of the QA plans and product resource and capacity overview
  • Assisting with the resolution of quality Dispute between CMO and UCB sites if needed
  • Ensuring review and approval of CMC sections linked to original submissions or variations
  • Supporting preparation and execution of product launches from QA perspective (e.g. launch strategy, align QA activities, submission review, attend launch team meetings,etc.)
  • Having the overview of UCB audit and inspections of CMOs and sites related to the product
  • Facilitating inspection preparation at UCB or CMO sites
  • Being the QA stakeholder for Product Risk management.
  • Working closely with staff in the Corporate QA teams (especially CMC Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for the Product are provided in an effective and efficient way.
  • Establishing key performance indicators (metrics) for key operational QA activities and services associated with the Product
  • As required, providing Operational QA support to other products

 

Vendor management:

Providing expert advice, support and management for technical operation QA and general QA matters for specific vendors involved, on behalf of UCB, in the manufacture and/or testing of Evenity. Specifically focus on the following:

  • Negotiating and setting of Quality Agreements
  • Monitoring and trend 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
  • Facilitating 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

 

Quality systems:

Be the main Biologics Quality Operations representative for Quality Systems projects and initiatives:

  • Being an active member of the QMS Lifecycle Management Board
  • Leading SOP periodic review
  • Maintaining the Training matrix for the team
  • Implementing and track quality KPIs
  • Being the team representative for specific QMS projects
  • Maintaining GMP compliance and inspection/audit readiness at all times.
  • Supporting Head of Biologics Quality Operations in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments.

 

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

  • Master’s degree related to the field of activity
  • Minimum of 10 years working in the pharmaceutical biological industry in a GMP operational quality management position.
  • In-depth knowledge and understanding of applicable regulations, quality principles, relevant business processes and techniques in particular related to manufacturing activities of biological and sterile products, CMO management and Quality Systems.
  • Experience interacting with third party organizations with respect to QA systems and regulatory inspection preparedness.
  • GMP Auditing expertiseTeam player, nonhierarchical management skills (persuasion)
  • Autonomous, self-starting attitude, problem solving oriented, pragmatic
  • Ability to balance efficiently multiple priorities
  • Strong both analytical and conceptual thinking, able to understand and get clear picture on complex, technical and business issues
  • Ability to lead multi-functional teams, influence others, hold teams accountable, results orientated, effective at networking, able to manage complex projects from development through commercialization and to attain results
  • Must be able to manage external business partners and relationships to influence partners to deliver results that UCB needs
  • Relationship management – internal/external, ability to work through internal and external networks (including external potential partner assessment)
  • GMP regulated environment and safety regulation knowledge
  • Understanding of finance with specific focus on CoGs and investment decision making
  • Direct experience in commercial manufacturing (technical)
  • Ability to develop and implement strategic initiatives. Must be able to coordinate and work in teams. Must have the ability to continue to develop to reach a senior role.

 

Leadership skills:

  • Must be able to act without direct supervision and handle complex/difficult situations. Output from 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 project 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
  • Mobilizes relevant colleagues, business partners and other stakeholders when facing obstacles
  • Demonstrates an ability to influence different audiences
  • Takes initiative 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 departmental/company vision.
  • 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 demonstrates initiative and the 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 leveraged from extensive quality experience.
  • Demonstrates accountability for decisions and actions taken

 

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 demonstrates initiative and the 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 leveraged from extensive quality experience.

 

To apply please go to www.ucb.com/careers

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers


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