QA Manager
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Job Description
QA Manager overseeing quality assurance programs for clinical research. Supporting compliance and quality initiatives at IQVIA across various regions.
Responsibilities:
- 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, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives.
- 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 etc.
- Ensure the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management 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 to reflect the status of audits being scheduled, auditor assignment and audit reporting and/or follow-up status.
- Host customer audits, mock regulatory inspections, and regulatory facility inspections as needed.
Requirements:
- Bachelor’s degree in Life Sciences
- Clinical Research background with extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- +4 years Quality Assurance experience in pharmaceutical, technical, or related area.
- Considerable knowledge of quality assurance processes and procedures.
- Knowledge of word-processing, spreadsheet, and database applications.
- Experience in audits/inspections is a plus
- Advanced English level
- Strong interpersonal and communication skills.
- Excellent problem solving, risk analysis and negotiation skills.
- High tolerance to stress; calm and composed demeanor
- Exceptional training capabilities.
- Effective organization, team orientation, and leadership skills.
- Ability to work independently with initiative.
- Ability to manage multiple projects.
Benefits:
- Full remote role with occasional travel: 20–30% per year
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