Responsible for assisting with the internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards. 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.
· Assists with planning and conducting internal compliance audits of all operations within the facility.
· Hosts external auditors during site inspections
· Provides support with company and regulatory agency (i.e. DEA, FDA) inspections
· Follow up on audits to assure that action plans are developed and completed in a timely fashion.
· Assist with management review and associated metrics for the plant
· Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s)
· 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.
· Bachelor’s degree, preferably in science or Engineering, or equivalent work experience is required
· 3+ years of experience in medical devices, Experience with Class II and/or Class III medical device
· Experience coordinating recall/market actions
· Quality Assurance/Regulatory Affairs/Compliance preferred
· Knowledge of regulations and standards preferred
· Ability to evaluation quality, production and support areas for compliance to GMPs
· Ability to identify and investigate problems and help to resolve them
Essential Skills, Experience, and Competencies:
· Excellent verbal and technical writing skills with the ability to interface effectively cross-functionally and at all levels.
· Demonstrated leadership skills.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.