Quality and Training Advisor
- Experience Level
- Experienced (non-manager)
We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.
Who are we?
We Are PRA.
We are 17,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.
Who are you?
You are a leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty. You look for new and innovative ways to problem solve. You are the ultimate planner and coordinator and are an excellent communicator. You have a serious passion for clinical development. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.
What will you be doing?
The CCQM will oversee all Clinical Quality Management (CQM) related activities in the UK. The CCQM will work in close collaboration with the Clinical Research Directors (CRD) and the local clinical operations team. In addition, the CCQM will support CQM activities at the regional and/or global level as needed.
Specific responsibilities include:
Audits & Inspections: The CCQM will be the primary point of contact for Global Compliance and
Regulatory Agencies, manage and support activities during the preparation and ongoing phase of
an audit/inspection. In cooperation with the local team and/or headquarters, the CCQM will
perform a root-cause-analysis for audit observations/inspection findings, manage and track the
Corrective and Preventive Actions (CAPAs) as well as coordinate and facilitate the responses to
Processes & Regulations: The CCQM will be the local expert for ICH-GCP and local regulations.
In close collaboration with the CRD, the CCQM will manage the local SOP/SME network to
ensure a proper implementation of global/local procedures and the regular update of local SOPs.
The CCQM will also identify process improvement opportunities and/or process gaps and
properly escalate as necessary.
Training: The CCQM will be the local training point of contact and the liaison between local GCTO
and Learning & Development. In close cooperation with the CRD, the CCQM will identify local
training needs and initiate local training activities.
Quality Control (QC) Activities: The CCQM will ensure the proper execution of the In-house
Quality Control Plan (IHQCP) as well as the Quality Control Visits (QCVs). . Upon request and in
mutual agreement with the CRD and the RCQM, the CCQM may also perform QC activities
and site visits.
Vendor Qualification: The CCQM will lead local vendor qualifications of locally selected vendors
and supports solving of quality issues with locally selected vendors.
What You Need to Have:
- Bachelor's Degree or equivalent in relevant health care area.
- A thorough understanding of clinical research including direct field monitoring experience or management/ oversight of such individuals, with a demonstrated record of accomplishments
- Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
- Experience in managing audits and inspections is preferred
- Experience in coordinating and delivering training sessions is preferred
- Superior oral and written communication and people management skills in an international environment.
- Excellent project management and organizational skills.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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