Senior Compliance and Quality Assurance Consultant
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Qualified Person consultant leading GxP quality assurance, regulatory, auditing, QMS, and CAPA projects. ProPharma provides consulting solutions to biotech, medical-device, and pharmaceutical organizations.
Responsibilities:
- Serve as a key subject matter expert in assigned areas of quality assurance and regulatory/GxP
- Provide independent consultation and project leadership across CQA projects
- Lead and manage client MIA/WDA projects and PPG MIA license activities, including QP batch certification, GxP auditing, and QMS development
- Ensure successful execution and profitability of key projects
- Monitor regulatory and technological changes in the CQA field
- Contribute to risk-based and phase-appropriate GxP projects
- Act as SME in commercial processes and identify scope and effort required for client needs
- Promote CQA services across the industry
- Promote continual improvement in customer satisfaction
- Provide CQA-specific training to clients and associates
- Support clients and ProPharma functional units with GxP issues, including deviations and non-conformances
- Consult on CAPA implementation and support compliance with quality principles
- Participate in quality-system development through SOP writing and training
- Educate employees at all levels on compliance and quality assurance
- Perform the Qualified Person or Responsible Person function for clients, as applicable
- Perform other duties as assigned
Requirements:
- Ideally educated to at least a BSc level in Pharmacy or another appropriate discipline
- 10 years or more experience within Quality Assurance within GxP settings
- 2–3 years or more experience working as a Qualified Person
- Ideally skilled in development and marketed products
- Thorough understanding of the regulatory landscape, including US FDA, ICH, EMA, and MHRA
- Fluency in English and ideally one other EU language
- Demonstrated project management skills with the ability to prioritise workload and meet deadlines
- Excellent collaboration and stakeholder skills
Benefits:
- Remote working opportunity
- Competitive remuneration package
- Positive work-life balance
- Hybrid working encouraged for new hires based within a reasonably short commute of an office
- Equal Opportunity Employer workplace committed to diversity, equity, and inclusion
Similar Jobs
Senior Salesforce QA Engineer
Senior Salesforce QA Engineer testing Salesforce solutions for federal health programs and citizen services. Leading functional, integration, automation, security, accessibility, and release testing.
Senior Quality Assurance Engineer
Senior QA Engineer ensuring quality of web and mobile software for Slate’s affordable, customizable vehicles. Developing automated tests, frameworks, and quality-centric engineering practices.
Senior Quality Assurance Engineer
Senior QA Engineer automating Playwright/Python testing for Revenera’s cloud-based software monetization and analytics products. Validating APIs, UIs, data pipelines, and end-to-end workflows.
Claim Quality Assurance Supervisor – Material Damage
Claims QA Supervisor leading material damage, total loss, and salvage teams for specialty auto insurer Aspire General. Driving quality, compliance, coaching, and claims process improvement.
QA Engineer – Ultimate team
QA Engineer testing JetBrains IntelliJ IDEA Ultimate tools for JVM frameworks. Balancing exploratory testing, regression coverage, and automated test development for enterprise developers.
Quality Assurance Engineer III
Quality Assurance Engineer III driving automated software testing for Avalon Healthcare Solutions’ diagnostic intelligence platform. Ensuring reliable healthcare products through QA strategy, testing, and mentoring.
Quality Assurance Coordinator
Quality Assurance Coordinator supporting Clario’s clinical research and healthcare technology quality compliance. Coordinating audits, inspections, documentation, schedules, and regulatory readiness.
Quality Assurance Analyst
Quality Assurance Analyst testing Ava Industries’ cloud-based EMR software. Validating clinic workflows, releases, defects, and user experience for Canadian healthcare providers.
Product Tester – eBooks, Books
Product tester evaluating Aquana Publishing books and eBooks from purchase through delivery. Providing genuine reader feedback on content and customer experience.
Quality Assurance Analyst – Medical Facility Surveys
Remote QA Analyst reviewing CMS healthcare survey documentation for HMS, a healthcare quality services provider. Analyzing surveyor performance, training needs, and process improvements.
Senior Financial Crimes Quality Assurance (QA) Analyst
Financial Crimes QA Sr. Analyst strengthening BSA/AML, Sanctions, and Fraud oversight. Improving quality reviews and governance at Pathward, a financial empowerment company.
Financial Crimes QA Analyst II
Financial Crimes QA Analyst II reviewing BSA/AML, sanctions, and fraud oversight for Pathward, a financial empowerment company. Challenging decisions and improving regulatory risk governance.
Financial Crimes QA Analyst I
Financial crimes QA analyst reviewing BSA/AML, sanctions, and fraud oversight for Pathward, a financial empowerment company. Testing 2LoD governance, challenging decisions, and strengthening risk management.
Legal Engineer – QA
Legal Engineer improving legal AI quality for NetDocuments’ intelligent document management platform. Building evaluations, software tools, and agentic workflows for legal product teams.
Clinical Quality Assurance Coordinator
Clinical Quality Assurance Coordinator reviewing peer-review reports for MES Solutions, a provider of independent medical examination and peer review services. Ensuring clinical accuracy, compliance, and report quality remotely.
QA Audio Rater – English (Australia)
QA Audio Rater auditing audio-rating quality for Welo Data’s AI services in Australia. Identifying calibration issues and improving rater consistency during the pilot program.
Fullstack QA Engineer – MSME
QA Engineer owning manual testing for Salmon’s mobile, web, and backend fintech products. Testing APIs, releases, browsers, devices, and CI/CD workflows for MSME users.
Penetration Tester
Penetration Tester conducting web, mobile, API, and network assessments for Velero’s cybersecurity and compliance consulting clients. Delivering actionable findings that strengthen security posture and regulatory readiness.
QA Lead – Insurance
QA Lead Sênior estruturando estratégia, governança e testes para projetos complexos de seguros. Liderando equipes e garantindo qualidade, rastreabilidade e segurança nas entregas.
Senior Insurance Operations Quality Assurance Specialist
Senior QA specialist auditing complex Supplemental Health claims for Horace Mann, an educator-focused insurance and financial services company. Analyzing compliance, trends, and process improvements.