Head Qms, Doc and Training

Make your mark for patients To strengthen our Global QA Compliance Operationsdepartment, part of Internal Manufacturing Quality (IMQ) we are looking for a talented profile to fill the position of:Head of QMS, Documentation and Training- Braine l’Alleud, Belgium.

About the role
The Head of QMS, Documentation and Training, is a senior position within the Quality Compliance Operations team, reporting directly to the Head of QA Compliance Operations. The position focus will be to ensure strategic oversight, harmonization, and continuous improvement across all internal manufacturing sites and strong alignment with External Manufacturing organization, of Quality Management Systems (QMS) that include documentation & training, Regulatory Intelligence, Deviation, Investigation, CAPA, Change Control, Archiving, Metadata & workflow definitions etc. This strategic role ensures that the Quality Management Systems (QMS) across individual operational sites in UCB are implemented in an aligned manner and maintained continuously to meet regulatory requirements and internal corporate standards. While executing these Global activities the role needs to foster a culture of continuous improvement, process optimalization, driving operational excellence and implement process & value driven Digitalization, and collaborate with key stakeholders globally across UCB Units to uphold and enhance the organization’s quality standards. You will work with In this role, you will work closely with various stakeholders across UCB's internal and external manufacturing organizations. You will collaborate with the Internal Manufacturing Quality Assurance Leadership team, the QA Compliance Operations Leadership team ensuring alignment and harmonization of quality management systems (QMS) across all operational sites. Additionally, you will engage with the External Manufacturing organization to align processes. You will also interact with key stakeholders globally across UCB Units to foster a culture of continuous improvement, process optimization and wherever there is a process and value driven digitalization opportunity while supporting the organization’s quality standards. What you will do
- Lead a global quality team who supports operational and strategic activities, provide development opportunities while being value driven.
- Lead Gemba sessions across UCB Sites/ Departments to understand existing quality processes part of the role and systems, identify inefficiencies and identify Value Digitalization when needed.
- Oversee the implementation and ongoing improvement of Quality Management Systems (QMS) to ensure compliance with regulatory requirements and internal governances and policies.
- Drive the harmonization and standardization of quality practices across internal and manufacturing sites, fostering consistency and compliance globally.
- Support the Head Performance, Operational Excellence in driving Continuous Improvement initiatives aiming on enhancing efficiency, reducing risks, and maintaining high standards of compliance.
- Support the Head Audit and Inspection Readiness in managing risks and participating in audits and inspections when required.
- Lead regulatory intelligence activities, including compliance projects (e.g. china market compliance project)
- Promote a culture of innovation and continuous learning within the team and across the organization.
- Oversee and innovate training programs within IMQ to ensure staff are well-versed in regulatory requirements, quality standards, and operational processes.
- Oversee the training matrix, onboarding and development of people within the team.
- Serve as the transversal IMQ Single Point Of Contact (SPOC) for Quality Compliance topics below:
- CAPA management
- Deviation management
- Investigation management
- Change Control management
- QMS Documentation management
- Training management
- Archiving management
- Staff Qualification and training management (including GMP training)
- Regulatory Intelligence management
- Metadata and Workflow definitions
- Partner with key stakeholders to ensure alignment on quality processes and build regular networking communication (e.g. monthly meeting, monthly gemba...)
- Integrate any new IM UCB site into QMS through strategy definition while implementing onboarding plans, including training programs, documentation harmonization, Interested? For this position you’ll need the following education, experience and skills
- Bachelor’s, master’s degree or an education in a relevant scientific discipline
- Minimum of 10 years in Quality Assurance or/and Quality Systems Operations or/and Quality Compliance within a regulated pharmaceutical environment or equivalent
- Fluent English communication (oral and written); any additional languages are a plus
- Deep understanding of cGMP principles and global regulatory environments
- Proven track record in quality systems implementation
- Proven track record in leading a