Senior Associate QA for QC

Senior Associate QA for QC

Eli Lilly Benelux

Limerick, Ireland

Position Summary

We are seeking a highly motivated and detail-oriented Analytical QA Sr. Associate, to join our Quality Assurance team supporting our QCL laboratories and ensure the highest standards of product quality and compliance. This role is ideal for a strong QA representative with experience in analytical laboratory oversight, capable of thriving in a fast-paced, startup-like environment.

The successful candidate will provide QA oversight for laboratories and digital systems (e.g., LIMS, other e-systems), ensuring compliance, driving process improvements, supporting audits/inspections, and acting as a Business QA partner for lab e-systems.

Key Responsibilities

• Act as a primary QA representative for QCL laboratories, providing independent oversight and leadership.
• Lead QA support for deviations, change controls, risk assessments, and laboratory investigations, ensuring timely and compliant resolution.
• Maintain time-on-the-floor presence, monitoring compliance, data integrity, and adherence to GMP standards.
• Oversee digital systems and LIMS, including process data flow mapping, equipment/system qualification, and audit trails.
• Review and approve GMP documentation, procedures, sampling protocols, validation documents, and analytical methods.
• Drive process improvements across QC laboratories and digital workflows to enhance compliance, efficiency, and quality.
• Challenge QC operations and laboratory practices from a QA perspective, identifying risks, gaps, and opportunities for improvement.
• Ensure adherence to Good Documentation Practices and Data Integrity principles across all activities.
• Support regulatory inspections and audits, ensuring laboratory readiness and alignment with global standards.
• Mentor and coach colleagues, fostering a proactive quality culture and continuous improvement mindset.
• Support the broader QA for QC function as needed, contributing to cross-functional quality initiatives.

Mandatory Requirements

• Honours Degree (BSc, MSc, or PhD) in Microbiology, Biology, Chemistry, Pharmacy, Quality, Engineering, or related discipline.
• Minimum 3 years’ experience in Quality Assurance within biotechnology or pharmaceutical manufacturing.
• Experience with quality management systems (e.g., TrackWise, OneQMS).
• Proven expertise in:
  • Deviations, change controls, risk assessments, laboratory investigations, root cause analysis and process improvement.
  • QA floor presence for laboratories and supporting areas.
  • Equipment qualification requirements.
• Strong knowledge of cGMP, FDA/EMA regulations, Data Integrity, and Good Documentation Practices.
• Understanding of cross contamination requirements.
• Ability to work independently and in a fast-paced, dynamic environment.
• Excellent organizational, problem-solving, communication, and interpersonal skills.

Preferred Qualifications

• Knowledge or experience in microbiology or virology or cell-based assays or bioanalytical processes, biosafety assessments, and analytical method lifecycle management.
• Experience with LIMs (e.g. Labvantage, MODA) and other laboratory digital systems.
• Familiarity with QC laboratory operations and analytical testing.