QA Manager

QA Manager

Full remote role with occasional travel: 2030% per year

Job Overview
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

Qualifications
Bachelors 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. Equivalent combination of education training and experience.

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.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.