Senior Project Quality & Risk Lead
- Employer
- Parexel
- Location
- Harrow, United Kingdom
- Salary
- Competitive
- Start date
- 9 Jun 2019
- Closing date
- 3 Jul 2019
View more
- Discipline
- Quality, QA / QC
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Key Accountabilities:
Perform, report, and coordinate the quality evaluations for assigned projects
o Verify compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements
o Actively participate in key internal project team meetings and facilitate quality discussions during these meetings
o Schedule and lead the project related Quality Forums
o Attend client meetings with project team leadership to collaborate with and participate in discussions related to quality
o Provide quality advice to the project teams and participate in relevant project team training
o Provide support with investigation of Quality Issues (QIs) and support of QI management including classification of issues, assist in determination of root cause and consultation on appropriateness of corrective and preventive actions
o Provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on project related audit/inspection responses generated by project team members per applicable SOPs
Represent Quality Management in audits and inspections as required.
Mentor Project Quality & Risk Leads, as assigned
o Fulfill the mentor role for Project Quality & Risk Leads, as assigned
o Provide consultancy and guidance to Project Quality & Risk Leads, as assigned
Build and maintain relationships with clients / act as primary point of contact for communications with client quality representatives
Fulfill role of Portfolio Quality Lead, as assigned
Serve as quality consultant for assigned accounts to senior project leadership personnel and assist with the oversight of quality aspects of the client program
o Review key portfolio documentation from a quality standpoint
o Provide support and consultancy for portfolio quality issue
o Facilitate portfolio level compliance with the Corrective and Preventive Actions (CAPA)
o Coordinate Project Quality & Risk Leads assigned to the client as needed
o Provide audit and inspection support for portfolio, including, where feasible, advising the project teams during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on portfolio related audit/inspection responses generated by project team members per applicable SOPs. Represent Quality Management in audits and inspections as assigned.
o Oversee the collection and reporting of portfolio quality metrics. Evaluate the quality status of a portfolio by reviewing applicable quality metrics.
Identify process improvement opportunities
o Oversee the collection
o Report process gaps and participate in implementation of process improvement when required
Qualifications
Skills:
Knowledge and Experience:
Education:
Company
When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.
How to describe Parexel’s culture in one word:
Working With Heart™ - Christina's perspective:
Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.
- Website
- http://www.parexel.com/
- Telephone
- +44 1895 238000
- Location
-
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
United Kingdom
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