Clinical Quality Management Lead

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Date: Jul 8, 2019

Location: Monheim, Mettmann, DE

Clinical Quality Management Lead
Global Clinical Sciences & Operations
April 11, 2019 • Location: Monheim, Germany

 

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?


To strengthen our Global Clinical Sciences & Operations (GCSO) team, based in our affiliate in Slough, United Kingdom, we are looking to fill the position of: Clinical Quality Management Lead.


Is your analytical adeptness second only to your strategic capacities? At UCB, we know you as a ‘stratelytical’ person. This specific blend of talent means you are a deep-thinking planner devoted to improving patients' lives.


As a UCB 'stratelytical' person and Clinical Quality Management Lead you like to work in an environment where you can:

  • Lead/support GCSO in developing and maintaining its clinical quality systems/procedures and ensuring quality and compliance risks are appropriately identified and mitigated.
  • Drive a culture of continuous quality improvement, using quality by design principles, and will liaise closely with Clinical Quality Assurance.

 

As a UCB 'stratelytical' person and Clinical Quality Management Lead you will contribute by:

  • Leading and/or supporting GCSO quality and compliance infrastructure development; assisting with creation/revision of appropriate quality and compliance policies, SOPs, processes, and best practices as needed.
  • Educating, organizing, and coordinating information exchange with stakeholders at a global and local/regional level in alignment with the GCSO objectives and geographical footprint.
  • Owning the GCSO Quality Management System (QMS) which includes quality planning and quality control.
  • Leading improvement initiatives to improve quality and compliance processes and effectiveness in collaboration with stakeholders.
  • Developing metric reports for GCSO management of all issues related to the outcome of audits. 
  • Staying abreast with GCP, GLP, regulatory, and industry trends. Shareing key information gathered via professional associations and conferences (upcoming regulations, best practices) within the GCSO Practice, Global Regulatory Affairs, and Clinical Quality Assurance. 
  • Providing relevant GCP, GLP, and PV guidance and training to GCSO staff for all phases of clinical drug development.   
  • Partnering at all levels, including but not limited to, GCSO Line Management for staff assignment and audit/inspection coordination and serving as a point of escalation for resource coordination.
  • Conducting tracking and trending of SOP deviations in clinical studies and ensure the follow up on GCSO deviations with deviation owners.
  • Managing CAPA activity for internal (system) audits and findings from any audits and inspections where findings are raised to UCB in conjunction with department managers and subject matter experts. This includes CAPA tracking and monitoring for timely closure.
  • Partnering with colleagues/others to (proactively) identify and mitigate compliance risks, resolve potential compliance observations and escalate critical compliance risks to upper management.

 

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

  • Academic degree in natural sciences or a comparable qualification
  • Excellent working knowledge of GCP, GLP, and PV-related requirements, proficiency of regulatory and ICH guidelines 
  • Detail oriented with Quality Assurance and/or Clinical Development background with analytical and problem-solving skills, including application of root cause analysis
  • Ability to work effectively in a fast-paced environment with sense of urgency and proactivity
  • Project management skills; excellent planning and organizational skills
  • Ability to prioritize based upon the compliance and patient safety risk
  • Strategic and results focused - ability to overcome obstacles and achieve key outcomes, ability to challenge the status quo in a constructive manner 
  • Excellent communication and interpersonal skills - ability to effectively communicate (oral and written) to UCB sites, partners, vendors, and all levels of the organization 
  • Ability to effectively build partnerships and networks (internally and externally) effectively- identifies opportunities and takes actions to build effective relationships within team and with other areas
  • Ability to present complex projects and issues to senior management
  • Proactively identify, lead and resolve problems. This behaviour requires independent thinking and innovative generation of ideas/solutions, coupled with an awareness of the appropriate communication technologies 
  • Self-driven (start the analysis of situation and come up with proposals and solving issues) and analytical (logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions)
  • Pragmatic analytical mind-set to understand global and complex compliance issues


To apply please go to www.ucb.com/careers. 

 

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers


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