Quality Project Lead

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.

Qualifications :

• 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 AbbVies 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.

Additional Information :

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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time