Senior Quality Engineering Leader - Manufacturing

PowerToFly; New Jersey; On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie in New Jersey seeks a Senior Manager of Quality Engineering to provide leadership and technical oversight for a team supporting manufacturing quality, validation, and risk-based compliance decisions. You will manage resources and budget while ensuring cGMP standards and regulatory alignment across base operations and development initiatives.

You will partner with Manufacturing, Validation, Regulatory, and Quality Systems to drive quality improvements, manage change controls, and guide

Qualifications

• Bachelor’s degree in physical or life sciences, pharmacy, or engineering.
• Certified Quality Engineer or formal training in quality engineering or statistics preferred.
• 8+ years of experience in manufacturing, QA/QC, R&D in pharma/biologics/device/chemical industries.
• 4+ years of supervisory/technical leadership experience.
• Familiar with cGMP, quality policies, and regulatory requirements; able to supervise and communicate effectively.

Responsibilities

• Leads and develops a team of quality engineers supporting manufacturing quality oversight and compliance.
• Provides functional leadership for quality engineering across processes, equipment, utilities, and facilities.
• Provides technical direction for quality engineering in base business, development, tech transfer, and market expansion projects.
• Ensures validation and qualification strategies and lifecycle activities comply with AbbVie Quality Systems and regulations.
• Reviews gaps in quality and compliance and drives risk-based actions.
• Partners with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Development on compliant process implementations.
• Guides risk management activities, including assessments and mitigation planning.
• Oversees qualification/validation for equipment, processes, cleaning, utilities, systems, and methods.
• Ensures quality issues impacting product quality/regulatory compliance are addressed and escalated appropriately.
• Communicates status, risks, trends, and recommendations to management and budget for resources.

Skills

Quality engineering leadership

People management

Communication skills

Statistical quality systems

Education

Bachelor's degree

Job description

AbbVie in New Jersey seeks a Senior Manager of Quality Engineering to provide leadership and technical oversight for a team supporting manufacturing quality, validation, and risk-based compliance decisions. You will manage resources and budget while ensuring cGMP standards and regulatory alignment across base operations and development initiatives.

You will partner with Manufacturing, Validation, Regulatory, and Quality Systems to drive quality improvements, manage change controls, and guide