Job Details
Posted 17 July, 2026
Job Id: 628984
Quality Specialist, CQA
Job Description
The Clinical QualitySpecialist, under the direction of the CQA management team, will be responsibleto support Clinical Quality and their operations in ensuring compliance of the company’s clinical studies, vendor management, and inspection readinessaccording to approved procedures, global regulations and ICH, GxP requirements.
Position details:
·Support the processing of audit reports, change controls, deviation, andaudit plans
·Support CQA team in the coordination, investigation, escalation, andresolution of issues identified during Clinical Quality Operations
·Support scheduling of audits with internal and external stakeholders
·Collect and generate metrics for Clinical Quality Operations.
·Assist in gathering requirements for improvements and ongoing maintenanceby participating in meeting/workshops with Site Process Owners and businessSMEs
·Participate in CQA meetings and the additional forums including but not limitedto Inspection Readiness and Regulatory Inspections
·Assist Clinical Quality in supporting internal and external stakeholdersin the processing of deviations, Quality Investigations, and audits
·Follow-up on requests, issues, and projects and report statuses tomanager and CQA team
·Support the management and maintenance of the Clinical Quality VendorManagement database.
·Provide CQA support through training management and onboarding of new employees.
ACADEMIC/TECHNICAL QUALIFICATIONS:
·Bachelor’s degree or higher in relevant computer, technical, quality, scientificdiscipline, preferably multi-disciplinary with a strong technical and qualitybackground
·Minimum of 2-5 years of experience in commercial pharma, CRO, clinicalpharma, or healthcare facility
·Proficient in MS Word, Excel, and Quality System processes. Experiencewith Veeva, TrackWise, and ComplianceWire is a plus.
·Understanding and working knowledge of US FDA and European regulatoryrequirements. Knowledge of Regulatory Compliance, ICH Guidelines, GxP standards
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
