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

Global Quality Lead Clinical Auditing Systems & Compliance

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  68832

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?

Global Quality Lead Clinical Auditing Systems & Compliance

 

To strengthen our Global Quality Assurance department, based in our hub in Braine l’Alleud, Belgium or Monheim, Germany, we are looking for a talented individual to fill the position of: Global Quality Lead Clinical Auditing Systems & Compliance

 

As a UCB Global Quality Lead Clinical Auditing Systems & Compliance, you like to work in an environment where you can:  

 

  • Partner with internal and external business partners in driving quality into the clinical development portfolio across the UCB sites and departments and provide Clinical Development Quality input to cross functional teams dealing with complex and/or important projects and issues
  • Provide mentoring and guidance to other members of the Clinical Development Quality team, support the Global Head and/or Regional Heads by deputizing for them at meetings on request, and contribute to planning and resource prioritization decisions for Clinical Development Quality activities
  • Partner with Development Solutions, Global Medical Affairs, Global Clinical Safety, and Pharmacovigilance in driving quality into the clinical activities across the UCB sites
  • Provide quality and compliance oversight as well as investigative support to UCB activities regulated by Good Clinical Practices (GCP)

 

As a UCB Global Quality Lead Clinical Auditing Systems & Compliance, you will contribute by:

 

  • Functioning as a liaison during inspections and investigations conducted by international and national authorities, including responsibility for the preparation and hosting of UCB sponsor sites for inspections
  • Leading the development of a risk mitigation program for UCB clinical programs, prospectively identifying critical quality risk factors and their potential impact, and developing efficient processes or solutions to manage the risks
  • Independently planning, coordinating and executing Clinical Development Quality activities in accordance with the risk mitigation plans to validate the systems and processes established to ensure subject safety and protection and to ensure that clinical trials performed, and data are generated in compliance with international and national GCPs
  • As required, reviewing and coordinating the output of trends from audits and risk analyses prepared by colleagues, providing senior management and peers in other departments with a summary and analyses of the comparative risks and outcomes across multiple clinical programs
  • Ensuring resolution of audit findings through close collaborations with business partners, stakeholders, and vendors. Utilizing in-depth knowledge and understanding of current business trends, applicable regulations and quality principles, collaborating effectively and influencing approaches to quality, and ensuring work products and output are aligned with regulatory guidelines, ICH-GCP, other applicable regulatory requirements and UCB global quality standards
  • Representing Clinical Development Quality at interdepartmental and project team meetings taking the leadership role when required, and dealing with complex and difficult or important project issues
  • Delivering presentations to peers, senior management, and industry audiences, acting as a role model for change
  • Helping develop and retain talent, coaching and mentoring junior colleagues, generating enthusiasm and encouraging new ideas
  • Ensuring that execution of outsourced audits are conducted and completed in alignment with UCB audit processes and standards

 

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

  • Bachelor’s or master’s degree in a relevant discipline
  • In-depth knowledge and understanding of ICH-GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques.
  • Strong background, knowledge and experience of the (bio)Pharma industry and applicable technical aspects of the business.
  • Extensive experience performing GCP related audits: leading audits (investigators, vendors, systems) and support inspections
  • Develop robust clinical quality risk management programs
  • Proven experience in Project Management experience
  • Leadership skills : ability to convince, influence and support the teams/stakeholders in their activities
  • Full proficiency in English

In addition:

  • Organize; manage and empower teams to execute quality strategies to minimize quality risks
  • Assure that systematic and planned actions are established to ensure as clinical trial is performed, data generated, documented and reported are in compliance with GCP and applicable regulatory requirements and company procedures
  • Manage outsourced investigator site audits by meeting projections and financial budgets
  • Effective communication skills by having the ability to articulate oneself and be a good listener
  • Adaptable and flexible to change, strong leadership skills when necessary
  • Influence senior management and external peers on project related issues
  • Lead project related teams within area of expertise
  • Take initiative to identify and deal with issues within area of expertise
  • Identify need for management of change and recommends appropriate methodologies
  • Coach, mentor and train colleagues as requested by line management
  • Deliver or provide input to training programs within area of expertise
  • Capable of leading and motivating interdepartmental teams
  • Inspire confidence at senior levels through influencing skills and technical ability
  • Demonstrated professional maturity in stressful situations or conflicts.
  • Know how and when to give praise/recognition or constructive feedback
  • Thorough understanding of business and cultural drivers
  • Skilled and experienced at operating in a cross-cultural team environment and understands principles of cost-and time efficiency
  • Foster professional growth and team spirit
  • Set challenging objectives for the (project) team
  • Set business objectives for self that are achievable, measurable and time-based
  • Demonstrate initiative and an ability to help team and others solve problems creatively and practicality
  • Use colleague's and business partners' skills and abilities effectively
  • Ability to take a leadership position when working in a group
  • Commit significant time and resource to improve performance
  • Continually strive to develop new methods
  • Achieve results that are aligned with the BU/project target
  • Identify risks and propose corrective actions in complex situations
  • Apply appropriate strategies and option-based rationale
  • Apply best practices, principles and theories in complex situations and issues
  • Give input based on expertise and awareness of business implications
  • Implement risk-based approach
  • Take innovative approach to working practices
  • Handle complex situations
  • Develop efficient processes or solutions without active supervision
  • Involved in difficult or sensitive projects
  • Generate enthusiasm and commitment to our vision
  • Generate enthusiasm and commitment to our strategic priorities
  • Encourage others to anticipate and accept change
  • Act as a role model who consistently support and endorse the vision
  • Anticipate what is significant for the future of our business within area of responsibility

 

 

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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