Sr. Quality Compliance Analyst

Job Description
Purpose
Under the supervision of the Manager of Regulatory Compliance, the Sr. Regulatory Compliance Analyst will support all aspects of the Regulatory Compliance processes which include but are not limited to the activities listed below. Ensures the organization’s compliance with FDA, ISO, AATB, and all other applicable international and state regulatory requirements, best industry practices, the harmonized corporate and internal processes. Compile Quality metrics for QSMR, Tier board etc. and identify and bring issues to management when a compliance gap or quality issue is identified.
Responsibilities
Supports/Leads the Branchburg internal audit program and leads/performs internal audits in accordance with the corporate harmonized policies, processes, procedures, internal procedures, and relevant standards/regulations.
Coordinates external inspections performed of AbbVie-Branchburg by regulatory agencies and business partners and supports the completion of audit responses as needed. Lead audit readiness preparation.
Supports/leads product significant events and market action activities and drafts/reviews all necessary documentation and correspondences between AbbVie-Branchburg, corporate, and regulatory agencies as required.
Manages the assessment process for new or revised external standards/regulations for applicability and impacts to the Branchburg Quality Management System (QMS) and products. Reviews/approves assessments completed by other functional areas.
Supports/Leads Quality assessments of major product/process changes or new markets. Identifies and communicates compliance risks to management to ensure appropriate actions are taken to remediate gaps or areas for improvement. Complete customer surveys as needed.