Head of Compliance

Jobinhalt

Make your mark for patientsWe are looking for a Head of Compliance who is rigorous, field oriented and able to lead a team to join us in our Sterile manufacturingdepartment, based in our UCB Campus office in Braine-l’Alleud, Walloon Brabant, Belgium.About The RoleAs part of the support to production and project activities in the Sterile Manufacturing department, the expectations of the Head of Compliance function are:

• You d eploy a Safe, Lean and Green mindset across the Sterile Manufacturing department.
• You e nsure daily management of the Compliance team.
• You c ollaborate 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 c ontribute to the Sterile manufacturing strategy and transformation, focusing on scale-up and launch of new products, complex technologies and small series.
• You are a k ey manufacturing representative and point of contact for operational excellence strategy development and projects.
• You p ro-actively implement and develop quality and functional excellence improvement aligned with business requirements when introducing projects or technical improvement.
• You s upport the management of deviations, investigations and associated CAPAs, changes control and the realization of the associated actions across the department.
• You s upport 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 m anage IN / OUT boarding.
• You m anage the implementation and management of KPIs and Hoshin.
• You e nsure 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.
• Ensure a strong collaboration with QA for all subjects related to GMPs.
• 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 implementation of the department’s Hoshin and ensure the monitoring of objectives and associated indicators.
• Implement and ensure the update of the Risk Register for the Department.

Interested? For this role we’re looking for the following education, experience and skills

• A master’s degree in the field or equivalent by experience
• A certification yellow or green belt in LEAN.
• Knowledgeable in regulatory requirements (cGMP) of the aseptic/sterile pharmaceutical industry with a comprehensive understanding of current regulatory requirements and ability to interpret current regulations.
• Knowledgeable in EHS related matters including behavior-based safety, risk management and communication.
• Demonstrated track record of direct exposure in audits, regulatory inspection by local and foreign authorities, including PAI and general GMP inspections as well as defense of difficult cases.
• Very organized, rigorous and autonomous
• Good communication skills
• Good oral and written knowledge of English
• Ability to lead a team
• Field oriented
• Knowledgeable in Problem solving and continuous improvement tools (5S, 6-sigma, Lean, Kaizen,..)
• 6-sigma certification is an asset (Yellow Belt or Green Belt)
• Analytical skills

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 UsUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work for 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 equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.Learn more about sustainability at UCB and how it is integrated into our business approach.UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.