IQVIA Argentina
Quality Assurance Manager
IQVIA Argentina, Ithaca, New York, United States,
We are seeking a
Quality Assurance Manager
to join Q² Solutions, IQVIA’s laboratory business in
Ithaca, NY.We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.As a
Quality Assurance Manager , you will 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. Act as line manager for one or more QA staff and oversee staff development and team deliverables. Manage the quality assurance oversight of projects, assignments, training and staff.What you'll be doing:
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.Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.What we are looking for:
Bachelor's degree required.7 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience. 5 years of management experience. Equivalent combination of education, training and experience.The Knowledge, Skills and Abilities needed for this role:
An excellent knowledge of current GXP regulations and guidelines and associated regulatory requirements.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. Effective organization, communication, team orientation, and leadership skills.Ability to work independently with initiative.Ability to manage multiple projects.Ability to manage staff. Strong training capabilities.Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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Quality Assurance Manager
to join Q² Solutions, IQVIA’s laboratory business in
Ithaca, NY.We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.As a
Quality Assurance Manager , you will 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. Act as line manager for one or more QA staff and oversee staff development and team deliverables. Manage the quality assurance oversight of projects, assignments, training and staff.What you'll be doing:
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.Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.What we are looking for:
Bachelor's degree required.7 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience. 5 years of management experience. Equivalent combination of education, training and experience.The Knowledge, Skills and Abilities needed for this role:
An excellent knowledge of current GXP regulations and guidelines and associated regulatory requirements.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. Effective organization, communication, team orientation, and leadership skills.Ability to work independently with initiative.Ability to manage multiple projects.Ability to manage staff. Strong training capabilities.Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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