Global Quality Lead Devices

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Date: May 5, 2019

Location: Braine L'alleud, Walloon Brabant, BE

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

Job location : Braine-l'Alleud

 

JOB SUMMARY

 

This position will drive operational Quality Assurance activities for development and commercial activities related to Medical Devices and Combination products internally and at key vendors. It will as well 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.

This position will ensure compliance to Medical Devices regulations, ISO requirements and GMP compliance from a quality, safety and efficacy point of view.

This position reports to the Head of Medical Devices QA.

 

MAJOR ACCOUNTABILITIES

 

Provide 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 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/commercialisation 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 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

 

EDUCATION & EXPERIENCE

 

  • Master's degree
  • Minimum of 5 years working 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 ISO13485:2016, MDR, ISO14971 and 21CFR820 and part 4 requirements

 

COMPETENCIES

 

  • Should have a 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 team work and take the initiative to promote and share/implement best practices.
  • 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.

 

UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system – or the central nervous system.

With more than 7500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.  Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at UCB.


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