Periodic Qualification Manager

Job Description

Make your mark for patients

We are looking for a structured, proactive, unifying Periodic Qualification Manager with a strong decision-making capacity to join our Qualification team, based at our site in Bulle, Switzerland.

About the position

As Periodic Qualification Manager, you will manage the Periodic Qualification team by defining its organization and priorities based on the site's challenges. You will guarantee the proper execution of periodic and mechanical qualification activities. You will also, with a high level of autonomy, take responsibility for the Qualification of major and strategic technical projects for the Bulle site, in compliance with internal procedures, regulatory requirements, and user needs.

The Periodic Qualification team covers activities related to Biotech, Pharma, and Chemical manufacturing environments, with a technical scope including HVAC systems, gas networks, SIP, autoclaves, and mappings.

The Periodic Qualification Manager plays a key role in the site's Qualification Operations organization. As a point of reference for periodic qualification activities and a Qualification expert on major or strategic projects, you will provide your expertise during investigations, Change Controls, and projects. You will contribute to the continuous improvement of processes, equipment, and systems, and ensure the backup role for the Qualification Operations Manager.

As a manager and technical reference, you will determine the qualification strategy for periodic activities and the projects for which you or your team are responsible. You will translate these into concrete priorities for your team. You will develop the autonomy and skills of your collaborators, foster collaboration, and promote a culture of performance and continuous improvement, in compliance with current Good Manufacturing Practice (cGMP) requirements, health, safety, and environmental (HSE) rules, as well as UCB values.

Your interlocutors

You will supervise a team specialized in qualification activities, for which you will organize resources and priorities in line with site objectives. You will collaborate closely with the Production, Utilities, Quality, Project Lead, and Engineering teams, as well as with external consultants, approved subcontractors, and cross-functional teams involved in major industrial projects.

Your responsibilities

• Manage the Periodic Qualification team, define a clear vision for the team, develop the skills of its members, and ensure the monitoring of objectives as well as individual and collective performance.
• Organize the team, manage resources, recruitment, workload, and priorities according to the needs, risks, and priorities of the site, while ensuring the quality of documentation, compliance with commitments, and satisfaction of internal customers.
• Drive activity planning, arbitrate priorities, adapt resource allocation, coordinate external service providers, and guarantee compliance with deadlines and objectives.
• Take charge, autonomously, of the strategy and Qualification management of strategic projects for the site, coordinate stakeholders, and guarantee the compliance of deliverables, the schedule, and associated decisions.
• Define the periodic qualification strategy as well as qualification strategies within your area of competence.
• Supervise the periodic qualification of facilities (HVAC, gas, mappings) in accordance with cGMP requirements.
• Supervise periodic SIP and autoclave qualifications in close collaboration with the Sterility Qualification Lead.
• Drive continuous improvement initiatives, manage deviations and Change Controls, and represent the team as well as the qualification process during audits and inspections.
• Act as a key reference point for the Qualification Operations team and ensure, when necessary, the backup role of the Qualification Operations Manager to support business continuity and decision-making.

Your profile: training, experience, and skills

• Master's degree in engineering or relevant higher education, ideally in a pharmaceutical, biotechnological, or technical field.
• More than five years of experience in the pharmaceutical and/or biotechnological industry, as well as more than five years of experience in facility and system qualification.
• Proven leadership and team management experience, with the ability to provide a vision, organize resources according to site priorities, arbitrate, decide autonomously, and lead large-scale cross-functional projects.
• Mastery of performance indicators and the ability to promote a culture of continuous improvement.
• Proven experience in periodic qualification (HVAC and gas) and thermal mapping.
• Excellent knowledge of cGMP, regulatory requirements, and controlled production environments.
• Good level of French and English, both oral and written.

Are you ready to -go beyond- to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don-t just complete tasks, we create value. We aren-t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We -go beyond- to create value for our patients, and always