Quality Assurance Engineering Lead

Quality Assurance Engineering Lead

AbbVie

Westport, Ireland

Purpose

The Quality Assurance Engineering Lead is responsible for providing quality assurance oversight for global engineering programs, which may include projects related to biologics (drug substance/drug product), API, aseptic manufacturing, terminally sterilized products, medical devices, and laboratory environments. This role ensures that quality and GMP requirements are incorporated throughout the project lifecycle.

As a member of the global engineering project team, this individual serves as the primary quality representative for key global engineering programs and collaborates with AbbVie site and engineering cross-functional teams to ensure GMP principles and contamination control requirements are upheld.

Responsibilities

• Provide quality assurance governance and oversight for global engineering programs, including projects related to biologics (drug substance/drug product), API, aseptic manufacturing, terminally sterilized products, medical devices, and laboratories.
• Provide quality assurance guidance during facility, utility, and equipment design reviews, as well as GMP reviews, from concept design through detailed design. Ensure identified risks are mitigated during the design phase.
• Lead contamination control risk assessments with cross-functional teams from AbbVie sites and global functional groups to ensure GMP regulatory compliance and to identify, evaluate, and mitigate contamination risks by design.
• Lead the development of the initial contamination control strategy for global engineering programs at AbbVie sites.
• Make key decisions regarding GMP and quality requirements for facility, utility, and equipment design, ensuring potential regulatory compliance risks and contamination risks are addressed during design.
• Partner with the project lead to provide updates on regulatory compliance risks and quality risks for inclusion in the project risk register.
• Participate in system risk assessments (SRAs) and review qualification documents, as required, in accordance with risk-based qualification requirements throughout the project lifecycle.
• Determine critical design elements impacting product quality and assess proposed test plans to qualify facilities, utilities, and equipment.
• Build strong relationships and collaborate with AbbVie site quality teams and cross-functional stakeholders to achieve quality deliverables, including GMP and quality risk mitigation for global engineering programs.
• Apply knowledge of aseptic manufacturing, terminal sterilization, API, and biologics (drug substance/drug product), including related facility, equipment, and utility GMP requirements.
• Maintain knowledge of applicable regulations and expectations from FDA, EMA, and regional health authorities.
• Apply quality risk management principles and contamination control strategy expertise to support compliant and effective project execution.

Qualifications

• Bachelor’s or Master’s degree in Engineering or a science-related discipline with relevant experience in some or all of the following areas: API, biomanufacturing, aseptic manufacturing, terminal sterilization, medical devices, and QC/microbiology laboratories.
• 8+ years of experience in the pharmaceutical industry in Quality Assurance, Engineering, Operations, or Technical Support.
• Demonstrated ability to operate in a fast-paced environment requiring urgency, flexibility, and the ability to manage multiple priorities while ensuring quality and GMP deliverables remain on schedule.
• Strong quality assurance mindset with experience in Quality Assurance, Engineering, Operations, or a technical discipline and a comprehensive understanding of biological and/or pharmaceutical technologies.
• Knowledge of pharmaceutical regulatory requirements and expectations supporting contamination control and GMP design requirements.
• Knowledge and experience with risk-based qualification, including ISPE Baseline Guide Volume 5: Commissioning and Qualification, and quality risk management principles such as ICH Q9.
• Self-directed and self-motivated with the ability to represent the quality function in a high-paced project environment.
• Ability to work closely with key project stakeholders to maintain delivery schedules and minimize potential delays.
• Excellent verbal and written communication skills.