Sr. Quality Compliance Analyst

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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.

Qualifications

• Bachelor's Degree, preferably in Science or Engineering, or equivalent related work experience is required.

• 3+ years quality audit experience ((preferred) minimum 4 years of Regulatory Compliance and/or Quality experience

• Experience with Class II and/or Class III medical device

• Experience coordinating recall/market actions

• Essential Skills, Experience, and Competencies:

• Excellent oral and technical writing skills with the ability to interface effectively cross-functionally and at all levels.

• Demonstrated leadership skills.

• ASQ Auditor Certification or ISO lead auditor certification preferred.

• Knowledge of applicable FDA and international standards/regulations including ISO13485, 21CFR820, 21CRFR1271, MDSAP, applicable EU medical device and animal tissue directives/associated standards, Canadian regulations for human tissue and/or medical devices and Australian TGA medical device regulations, EU MDD/MDR etc.

• Analytical skills and ability to