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Let's push the boundaries together and make the most of your talents!

Devices & Digital Biomarkers Quality Lead 1

Location: 

Bulle, Gruyere, Switzerland

Job Function:  Quality Assurance
Job ID:  69152

Devices and Digital Biomarkers Quality Lead

 

Help us transform patients' lives.

 

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

To strengthen our Global Quality Assurance department, based in our hub in Bulle, CH, we are looking for a talented individual to fill the position of: Devices and Digital Biomarkers Quality Lead

 

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

  • Partner closely with QA at UCB and vendor sites, and collaboration with UCB Technical Operations and other UCB teams.
  • Drive operational Quality Assurance activities for development and use of devices, softwares (SaMD) and wearables in clinical environment.
  • Work closely with internal and external business partners in driving quality into the clinical development portfolio across the UCB sites and departments It provides QA input to cross functional teams dealing with complex and/or important projects and issues.
  • Provide specific internal QA support/consultancy for development and commercial activities related to Medical Devices internally and at key vendors.
  • Act as QA specialist for medical device, SaMD and digital biomarkers to provide quality and compliance oversight as well as investigative support to UCB activities regulated by Good Clinical Practice for Devices
  • Implement and maintaining appropriate quality oversight processes to ensure compliance and support development activities
  • 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 Medical Devices QA.

 

As a UCB Devices and Digital Biomarkers 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, SaMD and wearables ensuring application of MDR, ISO and GMP/cGMP requirements. Specifically focused on the following

 

Development and Device clinical Quality assurance:

  • Overseeing intended use definition through verification, analytical and clinical validation activities
  • Reviewing and approving relevant sections of the device design control documentation and/or Technical Documentation File as required
  • Reviewing and approving protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc…
  • Reviewing and approving UCB documentation. Ensure Design History File (DHF) is in place
  • Supporting Risk Management Activities related to devices. Ensure risk assessments are performed at appropriate stages and for decision making on issues arising.

 

Vendor quality management

  • Overseeing partner and vendor selection by defining appropriate QA requirements for specific projects and devices use
  • Accommodating design & technology transfer and ensure systems alignment between vendor and UCB
  • Performing focused assessments/audits
  • Preparing and negotiating of Quality Agreements
  • Ensuring systems alignment between vendor and UCB
  • Facilitating quality improvement activities at vendors and UCB systems
  • Supporting risk register for the vendor, and following up on mitigation activities
  • Monitoring and trending vendor performance
  • Having the authority to accept release or block release of Medical Devices
  • Overseeing inspection plans at CMO and UCB

 

Quality processes

  • Facilitating investigations and resolution of issues relating to deviation and change management
  • Reviewing and approving deviations
  • Leading/reviewing critical investigations
  • Tracking CAPA events and closure
  • Overseeing/tracking 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…):

  • Acting as the Operational QA link between selected external vendors within the Medical Device portfolio
  • Assisting with regulatory and customer inspections at Vendors. Specifically focus on: Inspection preparation, Support during inspection, Support post inspection observation closure
  • Working 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
  • Working 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
  • Supporting additional projects as requested
  • Providing on-site presence ‘in plant’ or on site at vendor

 

General GMP:

  • Maintaining Quality System elements associated with the ISO, MDR and GMP activities in a compliant manner
  • Driving/Supporting projects related to quality system improvement
  • Maintaining key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices and Combination Products activities
  • Maintaining 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
  • Supporting Medical Devices related inspections
  • Supporting Management Review Process
  • Supporting Design Reviews

 

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

  • Master’s degree with a minimum of 5 years working in the pharmaceutical/biologics/medical devices industry in a quality management position. Operational GMP experience or clinical activities would be a distinct advantage.
  • Practical understanding of ISO 13485:2016, ISO14155, 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 team work 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 analyse 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.
  • Demonstrates initiative and the ability to help others solve problems in a creative and practical way.
  • 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. 

 

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

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