Quality Assurance Manager
Pennington, NJ 08534
- Develop, direct and implement Quality Systems/Programs to ensure compliance to company standards, Industry standards and Regulatory Requirements.
- Ensure that Clinical studies are conducted in compliance with study protocols, GCP, GLP and federal guidelines.
- Manage the SOP Process including the identification, development, approval, implementation, periodic review, revisions, controls and archival of all SOPs.
- Understand quality by design and implement a risk-based approach in auditing process. Responsible for the auditing of clinical trial sites (Investigators) during various phases of a clinical research study (as applicable), vendors and contract research organisations.
- Stay updated with Quality Assurance and regulatory trends, develop and implement recommendations regarding actions necessary to assure ongoing compliance.
- Provide guidance and training to the investigator sites /Clinic team as when required.
- Perform all activities in compliance with company SOPs, safety standards, study protocols, GCP and regulatory requirements
- Audit data and clinical study reports. Conduct in-process, on-site process and facility audits, and serve as a resource on the interpretation and application of regulations.
- Participate and assist with regulatory inspections.
- Prepare and retain written reports on audits, inspections and disseminate them to Quality Management, Head of Clinic and appropriate personnel.
- Assess the adequacy of responses (CAPA plans) to audit findings.
- Review and approve Installation Qualification (IQ) and Operational Qualification (OQ) documents relating to concurrent validation activities as and when required.