Head of Compliance
Il y a 2 mois
**Make your mark for patients**
We are looking for a **Head of Compliance** who is **rigorous, field oriented and able to lead a team** to join us in our **Sterile manufacturing **department, based in our **UCB Campus** office in **Braine-l’Alleud, Walloon Brabant, Belgium.**
**About the role**
As part of the support to production and project activities in the Sterile Manufacturing department, the expectations of the Head of Compliance function are:
- You deploy a Safe, Lean and Green mindset across the Sterile Manufacturing department.
- You ensure daily management of the Compliance team.
- You collaborate with Head of Sterile Manufacturing to pro-actively implement and develop cost, quality and operational excellence improvements aligned with business requirements.
- You are accountable for FDA/EMEA/RoW compliance for the Sterile Manufacturing department.
- You contribute to the Sterile manufacturing strategy and transformation, focusing on scale-up and launch of new products, complex technologies and small series.
- You are a key manufacturing representative and point of contact for operational excellence strategy development and projects.
- You pro-actively implement and develop quality and functional excellence improvement aligned with business requirements when introducing projects or technical improvement.
- You support the management of deviations, investigations and associated CAPAs, changes control and the realization of the associated actions across the department.
- You support the production in the management of incidents occurring during the filling and visual inspection activities to deliver a quality injectable product while respecting the safety rules and the department's objectives in terms of cost/time.
- You manage IN / OUT boarding.
- You manage the implementation and management of KPIs and Hoshin.
- You ensure risk management in the Risk register.
**What you’ll do**
- Participate and contribute to the definition of strategy (5-year plan) of the Sterile Manufacturing.
- Create engagement towards the UCB Vision, Values and Patient Value Strategy and its principles.
- Increase team's competency by ensuring adequate training, coaching and personal development plan in line with the team and people potentials.
- Define, communicate, put in place and maintain the organization which allows to reach these goals.
- Formally define objectives and assess the results with the adequate KPI covering HSE, quality and overall performance both for the individuals and the team.
- Address personnel conflict and performance issues in a timely manner.
- Ensure that the processes of recruitment, onboarding, integration and training are carried out.
- Support the sterile manufacturing (i.e. Production, NPI, Process engineer) in deviation management, CAPA and change control.
- Participate in the development and maintenance of the quality system in force in the sterile manufacturing.
- Be a driving force in continuous improvement by conducting internal audits / spot checks / GEMBA / Kaizen events and translating them into action plans.
- Support the sterile manufacturing (i.e. Production, NPI, Process engineer) in the optimization of flows and other improvement actions.
- Contribute actively on preparation activities and participation in department audits / inspections.
- Maintain teams and areas in Permanent Inspection Readiness mode.
- Ensure alignment and mentoring, advice, coaching to develop competencies of the Production team officers for aspects related to quality systems (dotted line link with their line manager).
- Ensure that the staff has an up-to-date training plan; monitor the department's training indicators, update training materials and the Talent Share tool; assist the Production team leaders with the theoretical training of operators.
- Actively communicate on HSE, Quality, smarter ways, BSC and KPIs across the sterile manufacturing.
- Perform trend analysis of the different systems and propose improvement ideas to robust practices.
- Ensure compliance with current legislation, internal safety rules and preventive actions,
- Monitor HSE indicators and assist the department in the implementation of HSE CAPA's and the follow-up of near misses.
- Sponsor and support the department's initiatives to work in a safer and greener environment; promote working conditions that contribute to the well-being of the staff.
- Be aware of the green objectives for 2030, disseminate them and contribute to their achievement.
- Participate in the establishment of smarter ways and define the gains associated with Operational Excellence.
- Participate in the elaboration of new improvement projects linked to the development of the activity in compliance with procedures,
- To be the guarantor of the Operational Excellence culture and to propose actions/projects/ways-of-working to improve it.
- Coordinate 5S activities (Participation in 5S audits and compliance with standards).
- Participate in the implementat
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