Head of Production Injectables

仕事内容

To strengthen our Braine Technical Operations – Sterile Manufacturing team in Braine-l’Alleud (Belgium), we are looking for a talented individual to fill the position of: Head of Production Injectables.

As our Head of Production Injectables, you like to work in an environment where you can:

• Ensure daily management of the Sterile Forms Manufacturing Production Activities (filling, visual inspection and maintenance)
• Supply development / commercial production volumes with quality products and related services in a compliant, time and cost-effective manner
• Ensure that sterile products are manufactured and released on time in full while complying with Environmental and cGMP requirements applicable to the site
• Collaborate with Head of Sterile Manufacturing to pro-actively implement and develop cost, quality and operational excellence improvements aligned with business requirements
• Be accountable for FDA/EMEA/RoW compliance for the Sterile Forms Production Operations
• Support the capacity and capability ramp-up of the Sterile Forms Production activities
• Contribute to the Sterile Forms Production strategy and transformation, focusing on scale-up and launch of new products, complex technologies and small series.

You willcontribute by:

• Participating and contributing to the definition of strategy (5-year plan) of the Sterile Manufacturing production activities and deploy to operations teams
• Developing a matrix organization to optimize customers satisfaction
• Creating engagement towards the UCB Vision, Values and Patient Value Strategy and its principles
• Increasing team’s competency by ensuring adequate training, coaching and personal development plan in line with the team and people potentials
• Defining, communicating, putting in place and maintaining the organization which allows to reach these goals
• Formally defining objectives and assess the results with the adequate KPI covering HSE, quality and overall performance both for the individuals and the team
• Addressing personnel conflict and performance issues in a timely manner
• Being accountable for sterile products compounding, filling/stoppering/capping, terminal sterilization and visual inspection, and all related processes, in order to meet commercial supply chain needs and development plans
• Working with team leaders to adapt and approve the production planning in cooperation with the Supply Chain
• Supporting the team leaders in setting up a fact-and-data approach based upon KPI’s for dealing with manufacturing topics
• Leading the team leaders to undertake, promote and supervise the capacity studies, the improvements of methods and equipment, safety and profitability to achieve the objectives
• Stimulating, sponsoring and supporting relevant initiatives into the department, aiming at working in a safer and greener environment
• Applying the company’s Health and Safety policy within the production zone
• Ensuring the respect of all applicable legislations (assistance of HSE manager if necessary)

Interested? For this position you’ll need the followingeducation, experience and skills:

• Master’s Degree
• 5-10 years’ experience in pharmaceutical regulated environment
• A minimum of 3 years in a leadership/management position and 5 years minimum in manufacturing
• Experience in continuous improvement Tools (TPM, 6-Sigma, etc…)
• Knowledgeable in regulatory and technical requirements of the aseptic/sterile pharmaceutical dosage forms,
• Demonstrated strong management background
• Knowledgeable in supply operations from S&OP to detailed scheduling
• Knowledgeable in EHS related matters including behavior-based safety, risk management and communication
• Comprehensive understanding of current regulatory requirements and ability to interpret current regulations
• 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
• Understanding of finance cost control and accounting rules
• Ability to take responsibilities and decisions
• Ability to be innovative, Entrepreneurship
• 6-sigma certification is an asset (Yellow Belt or Green Belt)

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.