Quality Project Lead

About AbbVie

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

We are seeking a Quality Assurance Project Lead for a 24 month Fixed Term Contract to join our Quality team and play a key role in driving quality culture initiatives, quality programmes, and site-based projects. This position will act as a quality representative on capital and new product introduction projects, ensuring quality requirements are embedded from planning through execution.

The successful candidate will bring strong project leadership, quality systems knowledge, and a proactive mindset to support compliance, continuous improvement, and inspection readiness in a fast-paced, matrix environment.

Purpose of the Role

The Quality Assurance Project Lead is a key contributor to onsite quality culture initiatives and will lead quality programmes such as Quality Risk Management and Data Integrity. The role supports the delivery of complex quality projects against agreed timelines while working collaboratively across functions and within a matrix structure.

Key Responsibilities

• Coordinate all aspects of assigned quality projects from initiation through completion.
• Lead quality planning and quality risk assessments.
• Drive quality continuous improvement activities and embed an operational excellence mindset across quality initiatives.
• Review and approve key quality documentation, including SOPs, protocols, change controls, ERs, CAPAs, and related documents as required.
• Support supplier qualification activities.
• Develop and monitor data analytics and quality metrics for the Quality department.
• Provide quality input into regulatory strategies and filings.
• Coordinate and participate in internal and external audits.
• Identify current process challenges and convert known issues into FMEA reviews and risk-based actions.
• Ensure ongoing compliance and inspection readiness.
• Participate fully in project team meetings and chair meetings where required.
• Act as a site subject matter expert on quality-related issues and provide guidance to colleagues across the department and site.
• Contribute to site capital projects and network programmes.
• Provide technical leadership and collaborate effectively with key stakeholders.
• Support talent development by selecting, motivating, training, and developing team members.
• Contribute to succession planning, performance management, and development planning where team leadership responsibilities apply.

• Degree or higher qualification in Quality, Science, or a related discipline.
• Minimum of 5 years’ experience in quality or manufacturing roles.
• 4+ years’ previous leadership experience in project leadership and/or people leadership.
• Experience in large product transfer projects is an advantage.
• Previous experience in sterile or OSD environments is preferred.
• Strong knowledge of GMP, compliance, and quality risk management principles is essential.
• HPRA and FDA experience is an advantage.
• Background in QC and/or QA is preferable.

Core Competencies

• High attention to detail and strong focus on accuracy and compliance.
• Innovative thinking with the ability to propose, test, and implement new solutions.
• Strong problem-solving skills and adaptability to changing requirements.
• Results-driven with a commitment to meeting targets and metrics.
• Strong prioritisation skills for self and team workload based on business needs.
• Commitment to quality, integrity, and high standards of work.
• Excellent verbal and written communication skills.
• Strong interpersonal and influencing skills.
• Supports the principles of Perfect Performance.

Behavioural Expectations

Ownership and Accountability

• Ensure compliance with procedures, policies, guidelines, cGMP, HPRA/FDA regulations, and company standards.
• Demonstrate a Right First Time mindset.
• Quickly build understanding of products and processes to assess quality issues effectively.
• Work with autonomy and strong initiative.
• Show persistence and tenacity to drive issue closure.
• Maintain compliance of validated systems and ensure changes are properly documented and actioned.
• Take ownership of the area during regulatory inspections and corporate audits.

Decision Making and Impact

• Manage day-to-day quality and compliance issues related to the programme.
• Escalate major issues to the Site Quality Head as appropriate.
• Present technical data to stakeholders to support timely decision-making.

Supervision and Working Style

• Largely self-managed, with regular alignment to the Site Quality Head.
• Works cross-functionally to ensure milestones are achieved.
• Performance goals are reviewed regularly, with formal performance reviews completed annually.
• Where applicable, responsible for goal setting, reviews, development plans, and performance management for direct reports.

Health, Safety, Environment and Energy

All employees are expected to support and comply with AbbVie’s EHS&E standards, policies, and procedures. This role requires strong commitment to creating a safe, compliant, and responsible working environment, and to actively participating in relevant EHS&E programmes.

Closing Date 26th June 2026

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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