Quality Assurance Manager
hace 7 meses
**Job Overview**
We are seeking an experienced Quality Manager to oversee & coordinate assigned Quality Management system program elements in support of Patient Centered Solution functional areas, internal effectiveness review processes, audit support, and overall support of a healthy quality management system. This role shall participate in promotion of compliance with regulations, guidelines, internal written procedures, risk identification and continuous improvements initiatives.
**Responsibilities**
- Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, standard operating procedures, and policies.
- Further develop, maintain and drive internal effectiveness reviews of internal processes/projects.
- 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 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.
- Write and revise quality management procedures as required.
- Support assessing, mitigating risks identified within the applicable functional areas.
- Define and solution efficiency and process improvements that will benefit multiple functions within the organization.
- Participate in off the shelf software validation and risk assessment activities.
- Plan, organize, and carry out internal audit/ effectiveness checks of applicable functional areas.
**Qualifications**
- Bachelor's Degree or equivalent working experience within regulated life science industries.
- 7 years Quality Management experience in pharmaceutical, medical device, technical, or related area. Equivalent combination of education, training and experience.
- Extensive knowledge and aligned experience with internal auditing.
- Knowledge of software development processes and GAMP5 requirements.
- Knowledge and experience within a GCP regulated industry.
- Considerable knowledge of quality management processes and procedures
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