Principal Quality Auditor – GCP
Precision Medicine Group
Google Cloud Platform
Clinical Quality and Compliance Lead
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud PlatformTableau
About the role
- Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies
- Participates in regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs
- Maintains IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews
- Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations
- Facilitates risk updates to R&D Business Partners through cross-functional trial-level meetings and/or Quality Working Groups and Governance Forum
- Actively identifies and escalates new central risk concerns to management and highlights potential systemic risk to BRQC QP&S management
- Develops and ensures a consistent interpretation of issues that require quality investigations and provides guidance for significant quality issues (SQI)
- Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities
- In collaboration with BRQC partners, advises on development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks
- Pre-submission Quality Stage Gate Review (SGR) support: supports SGR content development & follow-up activities
- Inspection readiness and preparedness support: develops ongoing trial oversight, inspection narratives, identifies and prepares sites of interest for inspection, ensures availability of key documents/records, and coordinates mock inspection with Regulatory Compliance teams
- Provides back room support for Sponsor-Monitor inspections at J&J Sites including post inspection support and inspection support per contractual agreement for third party inspections
- Provides remote support for investigational site inspections including post inspection support
- Provides independent consultancy advice on research quality and compliance and ensures consistent interpretation of international regulations and policy
- Post-licensing and Acquisition/Integration support: coordinates quality integration of acquiring assets/partners, delivers documentation within program/trial integration plans (90-day plan), executes assigned responsibilities, and provides guidance for asset divestment
Requirements
- A minimum of a Bachelor's or equivalent University degree (Scientific, medical, or related discipline) is required
- Proficiency in Microsoft Office Applications
- Proficiency in speaking and writing English
- Excellent interpersonal, oral, and written communication skills
- GCP quality and/or clinical trials experience
- Experience collaborating in a cross-functional team environment
- Flexibility to respond to changing business needs
- Demonstrates ability to operate in an environment of culturally diverse styles and business approaches
- Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP) (Preferred)
- Specific Therapeutic Area experience may be required depending on the position (Preferred)
- Experience with fundamentals of clinical trial risk management, preferably in a global setting (Preferred)
- Experience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance) (Preferred)
- Experience working to ICH guidelines (Preferred)
- Health Authority Inspection experience (FDA, EMA and other inspectorates) (Preferred)
- Strong Project Planning/Management skills (Preferred)
- Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related) (Preferred)
- Proven ability to analyze & interpret collective data to provide insights to drive decision-making (Preferred)
- Experience in managing escalations and CAPA support/advisement (Preferred)
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
- Well-being and work life balance opportunities for you and your family
- Competitive salary (mentioned)
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GCPclinical trialsrisk managementCAPAdata analyticsdata visualizationquality investigationsinspection readinessquality assurancequality control
Soft skills
interpersonal skillsoral communicationwritten communicationcollaborationflexibilitycultural awarenessproject managementanalytical skillsproblem-solvingdecision-making
