Regulatory Affairs Manager

Designation Manager, QRC Experience 5+ years Job Responsibility Responsible for ensuring SI products and services are compliant to relevant government and industry regulations including but not limited to: 21CRF11, ISO 27001, ISO 9001, ICH GCP, GAMP5, and Guidance for Industry - Computerized Systems used in Clinical Trials.

Assist in leading QRC for Quality Management System (QMS) development and improvement, training and process.

Assist in leading internal audits to assess compliance to SI QMS.

Represent or assist SI in external audits.

Provide project document and test review and approval in compliance with established SI software development lifecycle (SDLC) requirements.

Roles & Responsibilities Customer Audit Program: assist in scheduling, hosting, and follow up on all customer audits.

Provide responses to customer audit reports and follow up (to close out) on resulting corrective actions.

Carry out vendor audits, including on-site audit, providing vendors with formal reports which enumerate findings and observations requiring corrective action, and following up with vendors to assure that corrective actions are taken.

Support implementation and validation of internal computer systems (QMS, Training, CAPA) to support quality framework.

Support clients undergoing regulatory inspections in which company systems have been used.

To stay abreast of industry and federal regulations, and provide guidance and expertise to the global organization in the areas of regulatory compliance and quality.

Provide input and guidance from a regulatory and quality perspective to functional areas of the corporation to facilitate decision making related to product development/release, delivery of services and customer relations.

To maintain, modify and grow the corporate Quality Management System to comply with industry and federal regulations and corporate strategic goals.

To manage revision and approval of department Quality System Policy and SOPs.

Provide assistance and expertise toward the improvement of training programs across the organization and all functions.

To perform internal quality audits of the organization, including quality system inspection and reporting for all product releases and release of projects.

To maintain a cross-reference listing between the relevant sections and components of regulatory documents and the manner by which the Products and Services comply with those regulations cited.

Additional responsibilities would include, but not be limited to: Review products, systems, deliverables and documentation for: Conformance to regulatory requirements and applicable guidance worldwide Escalation of issues pertaining to non compliance, privacy, data integrity, and security for investigation and documentation of corrective and preventive action.

Develop, maintain, and report: Incidence of defects, audit findings and rates of occurrence and closure of outstanding issues.

Review process documentation for compliance to SOP’s and applicable regulations such as: Guidance and management of process and product improvement projects Review and resolution of QMS corrective actions and CAPA Plans Requirements Proven experience developing and managing Quality Processes, implementation of QMS Ability to conduct internal audits or manage external audits as an auditee Knowledge of the software development and testing process, especially for Agile development Ability to understand high-level technical concepts to provide review and commentary on project documents Excellent written communication skills in English Familiarity with regulated software requirements and standards Education Qualification Bachelor’s degree, preferably in a scientific discipline, Computer Science or any other related discipline with a MS degree being a plus.

Access Level Low Professional Qualification/certification Exposure on ICH-GCP guidelines and Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records, electronic signatures and computer system validation.