Devices Development Quality Lead

Job content

To strengthen our Global Quality Assurance team, based in our hub in Braine l’Alleud, Belgium, we are looking to fill the position of Devices Development Quality Lead.

As a UCB Devices Development Quality Lead, you like to work in an environment where you can:

• Drive operational Quality Assurance activities for development and commercial activities related to Medical Devices and Combination products internally and at key vendors.
• Provide specific internal QA support/consultancy for Medical Devices and Combination Products. This will be achieved through close partnering with QA management at vendors sites and collaboration with UCB Technical Operations and other UCB teams.
• Ensure compliance to Medical Devices regulations, ISO requirements and GMP/cGMP compliance from a quality, safety and efficacy point of view.

You will report to the Head of Pipeline Drug Delivery Devices Quality

As a UCB Devices Development Quality Lead, you will contribute by:

Providing expert advice, support and management for technical operational QA and general QA matters for specific vendors, on behalf of UCB, in design/development and/or testing/manufacturing of medical devices and combination products ensuring application of MDR, ISO and GMP/cGMP requirements. Specifically focused on the following:

Design and development Quality assurance:

• Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities)
• Review and approve relevant sections of the device design control documentation and/or Technical Documentation File as required
• Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc.…
• Review and approve UCB documentation. Ensure Design History File (DHF) is in place
• Support Risk Management Activities related to devices. Ensure risk assessments are performed at appropriate stages of development/commercialization and for decision making on issues arising.
• Ensure deliverables are issued in accordance with the D&D plan
• Review and approve submissions and responses

Vendor quality management

• Accommodate design & technology transfer and ensure systems alignment between vendor and UCB
• Performing focused assessments/audits
• Preparation and negotiation of Quality Agreements
• Ensure systems alignment between vendor and UCB
• Facilitate quality improvement activities at vendors and UCB systems
• Support risk register for the vendor, and follow up on mitigation activities
• Monitor and trend vendor performance
• Authority to accept release or block release of Medical Devices
• Oversee inspection plans at CMO and UCB

Quality processes

• Facilitate investigations and resolution of issues relating to deviation and change management
• Review and approve deviations
• Lead/review critical investigations
• Track CAPA events and closure
• Oversee/track change controls

Provide expert advice and support on operational and general QA activities for projects part of the devices portfolio (Process improvement, Technology Transfers, New products or life-cycle management…):

• Act as the Operational QA link between selected external vendors within the Medical Device portfolio
• Assist with regulatory and customer inspections at Vendors. Specifically focus on: Inspection preparation, Support during inspection, Support post inspection observation closure
• Work closely with staff in the Corporate QA teams (especially CM&C Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for selected critical vendors are provided in an effective and efficient way
• Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development
• Support additional projects as requested
• Provide on-site presence ‘in plant’ or on site at vendor

General GMP:

• Maintain Quality System elements associated with the ISO, MDR and GMP activities in a compliant manner
• Drive/Support projects related to quality system improvement
• Maintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices and Combination Products activities
• Maintain GMP compliance and inspection/audit readiness at all times. Support Medical Devices QA in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
• Support Medical Devices and Combination Products related inspections
• Support Management Review Process
• Support Design Reviews

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

• Master’s Degree with 5 years’ experience minimum in the pharmaceutical/biologics/medical device industry in a quality management position. Operational GMP experience or clinical activities experience would be a distinct advantage.
• Practical understanding of ISO 13485:2016, MDR, ISO 14971 and 21CFR820 and part 4 requirements.
• US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques.
• Take accountability for decisions and actions taken.
• Be proactive, confident and enthusiastic during the interaction with colleagues during teamwork and take the initiative to promote and share/implement best practices.
• Demonstrate leadership skills by ability to motivate, inspire others and resolve conflict
• Must be able to influence within cross functional teams to achieve a desired objective or outcome especially when working in a cross-cultural team environment.
• Share technical competencies through coaching/training team members when appropriate.
• Must be able to effectively interact with internal and external personnel on many aspects of project and product related matters. Be confident in providing constructive feedback (and accepting feedback) from colleagues
• Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental and external meetings. Ensure free flow of information throughout the sphere of work.
• Root cause analysis and risk management/assessment skills will be a distinct advantage.
• Demonstrate ability to independently analyze data and information to draw conclusions and make effective decisions.
• Must be able to identify and assess risks together with proposing corrective actions within area of expertise.
• Demonstrate initiative and the ability to help others solve problems in a creative and practical
• Must be able to coach staff and colleagues through effective problem solving to ensure the best resolution is obtained.
• Must be able to develop (innovative) solutions through judgment and reasoning leveraged from extensive quality experience.