Senior Clinical Quality Assurance Associate

Job Description

Full time

Location: Remote with some requirement to come into the Head Office at Welwyn Garden City, Hertfordshire

We are looking to recruit a new Senior Clinical Quality Assurance Associate to join the PHARMExcel team.

We are a dynamic Clinical Research Organisation (CRO) with a market leading reputation within the academic and commercial clinical trials market space. We support cutting edge clinical trials, meeting high regulatory standards with ground-breaking studies.

In this role you will be supporting the ongoing Clinical Quality Assurance (CQA) activities for the organisation, supporting our Good Clinical Practice (GCP) and Clinical Trial obligations, reporting to the Director of Clinical QA.

You will work closely with Clinical Operations, and other supporting areas/development teams, to help ensure active participation in continuous quality improvement activities.

What we hope you can bring to the role
You will be professional and demonstrate honesty and integrity. You will have a flexible and proactive approach with a ‘can do’ attitude. We are looking for someone who can accept and make changes in a fast paced environment and demonstrate a passion for the research environment, delivering high quality work.

Main requirements of the role:
· Develop and maintain ICH-GCP compliant processes and procedures which support the quality of work and clinical trials conducted at PHARMExcel.
· Support with performing Internal Quality Audits, CAPA (Corrective and Preventive Actions) Plans and Quality Management Reviews.
· Support the Director of Clinical QA with organisation and hosting of regulatory inspections and Sponsor/Client audits.
· Support with identification of non-conformances, provide suitable recommendations, and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable.
· Communicate any critical compliance risks noted from these activities to Director of Clinical QA.
· Support with performing external vendor audits and work with vendors and service delivery personnel in eliminating problems via root cause analysis techniques, to ensure that service delivery continuously improves.
· Assist in supporting training to PHARMExcel Clinical staff.
· Support and maintain the eQMS.
· Contribute to updates to and maintain CQA Standard Operating Procedures (SOPs) that support the Quality Systems.
· Prepare and support in preparing annual reports and quality trending reports to be presented to the senior leadership team.
· Keep up to date with all related quality legislation and compliance issues.
· Utilise guidance documents, international standards, or consensus standards and interpret for guidance.
· Co-operate with colleagues in Clinical, Regulatory, and Medical departments to increase the overall effectiveness of the quality role and instil a Quality Improvement approach in all activities.

About you

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Minimum degree (BSc) in Life Science or related discipline.
3 years + of demonstrated CQA experience in regulated industry such as pharma, biotech, CRO.
Full understanding of ICH/FDA GCP guidelines, with a working knowledge of GCP.
Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice.
Understand device regulations, development processes and FDA / EMA inspection procedures is also required.
Experience/Involvement

in FDA / EMA/UK inspections, working with regulators and customer audits.
Experience developing SOPs, reviewing internal clinical, regulatory, and medical processes to ensure they are accurately represented in current SOPs.
Good oral and written communication skills
Attention to detail
Time management skills
Demonstrated strong work-ethic
Outstanding customer service approach
Exceptional interpersonal skills

A competitive salary is being offered with other company benefits including private healthcare and company pension.

If interested please visit our website and submit your application and CV via the link https://pharmexcel-cro.com/careers or to receive more details please contact Dani Harrison Head of People & Culture at

dani.harrison@pharmexcel -cro.com

Closing date 31st May 2024
Interview dates TBC