Alliance Management Quality Lead

Contenido de trabajo

To strengthen our Global Quality Assurance team, based in our hub in Braine l’Alleud, Belgium, we are looking to fill the position of Alliance Management Quality Lead.

As a UCB Alliance Management Quality Lead, you like to work in an environment where you can:

• Be part of the Global Distribution and In-Market Quality Leadership Team (GDIM QLT), lead the Global Alliance Partners quality management activities and have the end accountability of the Alliance Management Quality operations.
• Promote strong collaborative partnerships with the stakeholder lines (e.g. ST&S, Global Regulatory Affairs, Commercial Operations, PVU’s) and other stakeholders to obtain a thorough understanding of potential areas of regulatory or safety risk.
• Articulate the goals and expectations, conduct timely and efficient internal communication of resource and data quality matters and partner closely with management to set objectives, and to achieve those objectives.

As a UCB Alliance Management Quality Lead, you will contribute with the following activities:

• Own a current inventory of the different of Alliance Partners (partners) where UCB QA involvement is required and act as the QA representative in ENG Partnerships governance body,
• Ensure partners are audited where required to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP according to the current risk assessment,
• Participate to partners audits and Business Review meetings as required,
• Ensure the creation, maintenance and approval of partners quality agreements and related appendices and storage in the UCB documentation management system,
• Review and approve sops, deviations, change control, recalls and complaints handling related to partners,
• Ensure timely communication of quality and compliance issues at partners according to the UCB escalation and recall processes
• Attend Escalation, Corporate Technical Review meetings and Recall Committees to assess the impact on partners and define related actions as needed,
• Manage communication with partners on multiple global quality topics, including review/approval of deviations, changes, recalls and complaints,
• Drive the identification of opportunities for improvement, development and
• implementation of quality and operational excellence projects in response to
• business requirements, technical changes, identified risks, audit observations
• and regulatory requirements for Alliance Partners Quality,
• Provide support to launches of global products with partners,
• Support partners in case of Regulatory Authorities activities impacting UCB products as needed,
• Host partner audits related to UCB global services,
• Participate to the preparation for UCB sites audits prompted by partners or partner authorities and provide direct support to System Owners and main customers during such audits,
• Be accountable for Alliance Partner Quality staff and talent management development, including performance management.

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

• Master’s Degree with 10 years’ experience minimum in biotech or pharmaceutical environment in commercial partner/vendor operational or quality management
• 10 years of Quality Assurance / Operational experience in pharmaceutical/ biotech industry.
• Broad knowledge, interpretation and application of processes and regulations governing commercial supply activities.
• Good knowledge of government regulations and guidelines (EMA, FDA, PMDA) pertaining to GMP.
• Experience in commercial partner/vendor management processes is an asset.
• English fluency is a must.
• Proven ability to function autonomously in a matrix model and in a team environment.
• Strong leadership ability.
• Good communication and interpersonal skills.
• Ability to work in a dynamic environment and to constantly redefine the priorities in alignment with compliance and business needs.
• Ability to freely travel a limited amount of time.