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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: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  68406

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

 

 

 

 

To strengthen our Clinical Quality Assurance Team, based in our RTP Office in Raleigh - Durham, NC, we are looking for a talented individual to fill the position of: Global Quality Lead -Clinical Auditing Systems & Compliance.

 

As a Global Quality Lead, you will be tasked with:

  • Partnering with internal and external business partners to help with 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
  • Providing mentoring and guidance to other members of the Clinical Development Quality team, supporting the Global Head and/or Regional Heads by deputizing for them at meetings on request, and contributing to planning and resource prioritization decisions for Clinical Development Quality activities
  • Partnering with Development Solutions, Global Medical Affairs, Global Clinical Safety, and Pharmacovigilance in drivinging quality into the clinical activities across the UCB sites
  • Providing quality and compliance oversight as well as investigative support to UCB activities regulated by Good Clinical Practices (GCP)

 

Major Accountabilities Will Include:

  • To function 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
  • To lead 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
  • To independently plan, coordinate and execute 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, review and coordinate 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
  • To ensure resolution of audit findings through close collaborations with business partners, stakeholders, and vendors. Utilize in-depth knowledge and understanding of current business trends, applicable regulations and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH-GCP, other applicable regulatory requirements and UCB global quality standards
  • To represent 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
  • To deliver presentations to peers, senior management, and industry audiences, acting as a role model for change
  • Helps develop and retain talent, coaching and mentoring junior colleagues, generating enthusiasm and encouraging new ideas
  • Ensure 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:

     Preferred Qualifications:

  • Bachelor’s Degree
  • In-depth knowledge and understanding of ICH-GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques.
  • 10 plus years of background, knowledge and experience of the (bio)Pharma industry and applicable technical aspects of the business.
  • 5-10 years’ experience performing GCP related audits.

 

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.

 

 

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything 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 worldwide 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. We are looking for people with passion and empathy who develop a real understanding of patient’s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

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. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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