GCP QA CAPA Manager
Job title: GCP QA CAPA Manager in Durham, NC at IQVIA
Company: IQVIA
Job description: By joining us as a QA CAPA Manager within Clinical Trials and GCP you will support global investigations and CAPA processes at IQVIA. This will include Quality Issue investigations and Customer Audit/ Regulatory Inspection Responses, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval, and closure. Preference is that candidate resides in EST zone.Your responsibilities will include:
- To lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures (SOPs) and project specific guidelines/instructions.
- Evaluate audit findings and prepare and distribute responses to operations staff and management.
- Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Provide consultation to staff in interpretation of audit observations.
- Manage Quality Issues and serious breach investigations.
- Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans. Track until closure quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.
- Present educational programs and provide guidance to operational staff on compliance procedures.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Assist in training of new Quality Assurance staff.
- Support in QA initiatives/projects for quality, process improvements.
- Manage/oversee quality events updates in eQMS.
- Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.
- Bachelor’s Degree in Life Science or related field.
- At least 5 years’ experience in GCP Quality Assurance within pharmaceutical, technical, or related areas.
- Considerable knowledge of GCP, clinical trial, regulations, and quality assurance auditing techniques.
- Fluent English language capabilities.
- Ability to work independently to problem-solve collaboratively and to raise issues appropriately as needed.
- Good interpersonal communication and organizational skills to establish and maintain effective working relationships with co-workers, managers, and sponsors.
- Good technology word processing, spreadsheets and database applications skills and knowledge of MS Office applications
- Consistent career growth.
- Leaders that support flexible work schedules.
- Programs to help you build your therapeutic knowledge.
- Dynamic work environment that exposes you to new experiences.
- Attractive benefits package.