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.
Essential Functions
- 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
- Bachelor's Degree Pref
- 7 years Quality Assurance experience in pharmaceutical, technical, or related area. Equivalent combination of education, training and experience.
- Knowledge of word-processing, spreadsheet, and database applications.
- 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..
