Jobs · Quality Assurance · New Jersey

Senior Supplier Quality Engineer

BioSpace · Branchburg, NJ · Today
Quality AssuranceFull-time

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 including immunology, oncology, and neuroscience—and products and services in our Allergan Aesthetics portfolio.

About the role

We are seeking a Senior Supplier Quality Engineer to help strengthen our supplier quality systems and ensure the highest standards of compliance, reliability, and performance across our global supply base. In this role, you will partner with suppliers and cross-functional teams to proactively identify risks, resolve quality issues, and drive continuous improvement.

Responsibilities

  • Monitor the performance of suppliers on a continuous basis and escalate any potential issues to supplier quality management.
  • Support the completion of supplier risk assessments and update the supplier quality database accordingly.
  • Ensure the supplier quality database is updated timely with any new information or additions, maintaining accuracy (e.g., supplier evaluation criteria, current supplier files).
  • Compile metrics for Supplier Quality Systems for internal stakeholders, tier boards, and Quality System Management Review.
  • Communicate supplier quality-related risks to the LifeCells business and management.
  • Support internal and regulatory audits on supplier quality-related requests.
  • Manage the supplier nonconformity process, including but not limited to:
    • Ensure all supplier-related NCRs are processed and closed in a timely manner.
    • Communicate supplier NCRs/SCARs to suppliers and ensure necessary follow-up actions are performed and documented per procedure requirements.
    • Obtain necessary documentation from suppliers to support material release at LifeCell.
    • Coordinate the review and approval of supplier NCRs/SCARs.
    • Work with suppliers to ensure investigations and CAPAs are robust and drive to root cause.
  • Ensure all supplier change notification records are created timely in Global TrackWise, and notifications for shared suppliers are communicated to the Corporate Supplier management group.
  • Assign assessment actions to SMEs and work with cross-functional SMEs and suppliers to complete assessments in a timely manner.
  • Provide feedback to suppliers regarding change notifications and ensure necessary follow-up actions are completed as required.
  • Follow up to ensure required internal changes resulting from supplier change notifications are implemented timely.
  • Coordinate the review and approval of supplier change notifications, ensure timely closure, and communicate assessment results to suppliers as needed.
  • Support the team in completing supplier audits as required per process requirements.

Qualifications

  • Bachelor’s degree, preferably in Biology, Chemistry, or Engineering.
  • 6+ years of overall experience in Manufacturing, Quality, or Engineering.
  • Good verbal and written communication skills.
  • Strong problem-solving and analytical skills.
  • Good interpersonal relations and communication skills.
  • Good negotiation skills.
  • Knowledge of quality/compliance management, as well as regulations and standards affecting API, Bulk Drug, or Finished Goods manufacturing.

Preferred Qualifications

  • Bachelor’s degree in Engineering is desired.
  • 5 years of experience with Supplier Quality, Supplier Change Notification, Supplier Audits, New Supplier Qualification, and Risk-Based Supplier Management is highly desired.
  • Experience in the Pharmaceutical or Medical Device industries is highly desired.

Additional Requirements

  • Willingness to travel domestically as needed, estimated at 10%.

Benefits

  • Comprehensive package including paid time off (vacation, holidays, sick).
  • Medical, dental, and vision insurance.
  • 401(k) retirement plan for eligible employees.
  • Eligibility to participate in short-term incentive programs.

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