Senior Manager, Quality Engineering

Responsibilities:
- Lead and develop a team of quality engineers supporting manufacturing process quality oversight, validation, qualification, and compliance.
- Provide functional leadership across manufacturing processes, equipment, utilities, facilities, and associated systems.
- Provide technical direction for quality engineering across base business operations, development, tech transfer, and market expansion projects.
- Ensure validation/qualification strategies, protocols, reports, and lifecycle activities comply with AbbVie Quality Systems, cGMP, and applicable regulations.
- Review quality and compliance gaps (processes, equipment, utilities, systems, change controls) and drive appropriate risk-based actions.
- Partner with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Development to implement compliant new/existing processes.
- Guide quality risk management (assessments, mitigation planning, risk principles).
- Oversee/support qualification and validation for equipment, processes, cleaning, utilities, computerized systems, and methods.
- Identify, escalate, and resolve quality engineering issues impacting product quality, process robustness, and regulatory compliance.
- Communicate quality engineering status, key risks/trends/recommendations; manage functional resources and budget.

Qualifications:
- Bachelor’s degree (preferably Physical/Life Sciences, Pharmacy, or Engineering).
- Certified Quality Engineer or formal training in quality engineering or statistics (preferred).
- 8+ years combined experience (Manufacturing/QA/QC/R&D) in pharmaceutical/biologics/device/chemical.
- 4+ years supervisory/technical leadership.
- Working knowledge of product physical/chemical characteristics (raw materials/manufactured products).
- Familiar with statistical quality systems, electronic document management, and LIMS.
- Familiar with quality policies, cGMP, and other regulatory requirements.
- Effective people management and communication; strong judgment; ability to work across manufacturing, materials management, engineering, product development, Quality Systems, Product QA/QC, IS, and Regulatory Affairs.
- Strong oral and written communication.

Preferred:
- Bachelor’s/Master’s/PhD in Life Science or Engineering.
- Strategic vision and leadership in building/sustaining high-performing teams.
- Strong cross-functional collaboration and negotiation; ability to influence stakeholders and drive outcomes.