QA Manager
IQVIA
full-time
Posted on:
Location Type: Office
Location: Reading • 🇬🇧 United Kingdom
Visit company websiteJob Level
SeniorLead
About the role
- Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level
- Provide support to management with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures
- Manage the quality assurance oversight of projects, assignments, training and staff
- Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
- Oversee and participate in the documentation, reporting, and closure of compliance issues
- Organize and deliver training to other IQVIA departments concerning the activities of Quality services, results of activities, quality initiatives, GXP
- Ensure the follow-up of major and critical audit findings to ensure appropriate actions have been taken
- Evaluate policies and procedures for compliance and provide recommendations for continuous process improvements
- Serve as author of Quality Assurance Standard Operating Procedures (SOPs) as assigned
- Advise Quality Assurance management on system audit needs
- Ensure the Quality Assurance database is maintained and up-to-date
- Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed
Requirements
- Bachelor's Degree Pref
- 7 years Quality Assurance experience in pharmaceutical, technical, or related area
- Equivalent combination of education, training and experience accepted
- Commercial Patient Support Program experience required
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments
- Considerable knowledge of quality assurance processes and procedures
- Strong interpersonal skills
- Excellent problem solving, risk analysis and negotiation skills
- Exceptional training capabilities
- Effective organization, communication, team orientation, and leadership skills
- Ability to work independently with initiative
- Ability to manage multiple projects
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality AssuranceComplianceRegulatory guidelinesQuality Management SystemStandard Operating Procedures (SOPs)Process ImprovementRisk AnalysisTrainingAudit ManagementDocumentation
Soft skills
Interpersonal skillsProblem solvingNegotiation skillsTraining capabilitiesOrganization skillsCommunication skillsTeam orientationLeadership skillsInitiativeProject management