Key Accountabilities :
Perform or assist the performing of quality assessments (e.g. quality gates, gap assessment, study file review), feeding back results to the Operational teams, Line Manager and Head of the Data Services QM as appropriate.
In conjunction with PAREXEL Academy, determine local training requirements (e.g. in quality processes, SOPs, software, etc.
and where needed support training delivery to ensure Operational staff have appropriate training per the functional curricula to support their role.
Working with the Business Process Management (BPM) group, ensure timely review and maintenance of Controlled Documents (e.
g. SOPs and Work Instructions) in accordance with the defined timelines (e.g. every two years).
Provides support and advice to Operational groups on the application of, and adherence to processes and the use of systems.
Supports Data Services QM and Operations staff at audits, client assessments or regulatory inspections, as needed.
Research and advise on relevant regulatory and industry trends and initiatives to ensure company stays current on GxP compliance issues.
Ensure knowledge of PAREXEL’s and third party vendors product lines.
Facilitate reporting, handling and follow up of Quality Issues.
Develop project plans for assigned projects in line with Operations and Data Services QM strategies.
Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.
Works closely with Operations management and with Line Manager to ensure continuous process improvement.
Represents Data Services QM at audits, inspections and client assessments, including preparation, conduct and follow up.
Where assigned, work with Operational groups to provide expert review of client-defined processes / quality and / or training materials.
Investigate internal quality issues, and provide suggestions for process improvements to the appropriate Operations team and Operations QM management. Monitor until resolution.
Monitors and reports on audit responses, providing metrics as appropriate. Supports staff in use of automated quality systems.
Confirms close-out of assessment findings, remediation of Quality Assurance audit and regulatory inspection findings in accordance with stated response times.
Reviews the results of operational QC processes. Initiates escalation of significant quality events to the Head of Data Services QM and the responsible Line Manager.
Using process mapping and analysis techniques identify areas for efficiency gains and process improvements within Operations and Quality groups, with subsequent development and implementation of action plans.
Represents the relevant functional group(s), or supports Line Managers / the Head of Data Services QM in representing the functional group(s), in cross-functional forums and initiatives.
Working with the Validation Services Group (VSG), assess technology that may include the evaluation of appropriate systems / software to increase quality and productivity.
Provide quality consultancy to Functional Leads, Line Manager and / or Project Leader / Project Leadership).
Complete or oversee the completion of assigned quality interventions / targeted / independent quality assessments. Develop designated Operational group(s) specific interventions / targeted / independent quality assessments as assigned.
Request audits of processes as needed.
Establish and implement standards and conduct continuous improvement activities based upon metrics, quality and other objective information, and conduct corrective and preventative actions (CAPA).
Will assume the duties of Quality Specialists and other duties, as appropriate.
quality issues and trends; audit findings and trends, process activities.
Basic understanding of Computer System Validation and Systems Life Cycle.
IT literate Experience with Microsoft based applications and general knowledge of PC functions.
Culturally aware and ability to think and work globally.
Ability to travel as needed for the position and to support other offices.
Excellent interpersonal, verbal and written communication skills.
Client focused approach to work.
A flexible attitude with respect to work assignments and new learning
Willingness to work in a matrix environment and to value the importance of teamwork.
The ability to work as a team member or independently, with minimal supervision is necessary.
The ability to gain trust and confidence with a variety of clients within PAREXEL.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Ability to effectively mentor less experienced members of staff.
Provide mentoring, leadership, direction and training to new and existing (Senior) Quality Specialists.
Fluent in written and oral English
Knowledge and Experience :
Experience in one or more areas of Data Services QM (e.g. process validation) or the functional areas that Data Services QM support.
Understanding of Clinical technology solutions is preferred.
Significant experience in a Quality / Regulatory / Quality Assurance / Training role.
Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Master’s degree in a science, technology or industry related discipline, preferred
Why Work at Parexel
There are pivotal moments in every career : Sharing new treatments. Improving processes. Delivering life-saving advances.
The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path?
A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That’s Parexel. We’re a diverse team of professionals focused on one goal : getting treatments into the hands of those who need them most.
Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.