Senior Quality Compliance Analyst

Somerville, New Jersey
Apr 01, 2024
Apr 06, 2024
Position Type
Full Time
Practice Setting
Work Mode
Employment Type
Organization Type
Corporation / LLC, Government
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 . on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

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 organizations 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 (CAPAs)

  • 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.

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

  • Demonstrated leadership skills.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.

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