To strengthen our Global QA Compliance Operations department, part of Internal Manufacturing Quality (IMQ) we are looking for a talented profile to fill the position of: Head Qualification, Validation, Digital and Data Integrity – Switzerland, Bulle
About The Role
The Head of Head Qualification, Validation, Digital and Data Integrity 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 of Qualification and Validation activities across all internal manufacturing sites; the coordination of Data Integrity Roadmap execution and monitoring; and align with processes being followed also by the External Manufacturing organization.
This strategic role ensures that Qualification, Validation, Digital, and Data Integrity systems across all UCB operational sites are designed, implemented, and maintained in a harmonized and consistent manner in alignment with the evolving regulatory requirements and internal company standards.
While executing these Global activities the role needs to foster a culture of continuous improvement, process optimization, driving operational excellence and implement process and 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 Qualification, Validation, Digital and DI activities, 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.
* Conduct 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 Computerized Systems Validation (CSV) and champion DI initiatives, ensuring compliance with global DI standards and best practices of industry.
* Oversee automation projects to optimize manufacturing quality executions.
* Ensure quality oversight across IM, including deviations related to qualification, validation, and testing executed.
* Coordinate the Data Integrity Roadmap execution, covering both paper documentation and systems.
* Drive harmonization and standardization of quality practices related to Qualification/ Validation, DI execution (DIRA, audit trail…) across IM sites, fostering consistency and compliance globally.
* Support quality improvement programs or/and initiatives aiming at enhancing efficiency, reducing risks, and maintaining high standards of compliance.
* Support audit and inspection readiness when required, ensuring sites are prepared for internal and external reviews.
* Promote a culture of innovation and continuous learning within the team and across the organization.
* 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:
* CSV, Testing and Access management
* Data Integrity (DIRA, audit trail...)
* Qualification management (IQ, OQ, PQ)
* Utilities, facilities
* Maintenance & Metrology
* 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 the Qualification, Validation, Digital, and Data Integrity framework by defining and executing a comprehensive strategy.
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 leading a team of people across the world
* Experience in participating in audits and inspections (FDA)
* Experience in Value driven Digitalization is a plus
* PMO, green belt, lean & six sigma is a plus
* Excellent organizational and analytical abilities to manage projects
* Expertise in data integrity, computerized systems validation, and process automation.
* Expertise with quality processes: maintenance & metrology, utilities, facilities, qualification (IQ, OQ, PQ), cleaning validation, disinfectant validation
* Exceptional communication and interpersonal skills for effective stakeholder engagement
* Strategic & Critical thinking with the ability to foster a culture of Quality, Continuous Improvement and Innovation
Are you ready to contribute to patient value? If this sounds like you, we would love to hear from you.
EEO Statement: UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
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