Company Profile
Our client a global, research-driven biopharmaceutical organization has a requirement for a QC Strategy Specialist to join their state of the art site in West Dublin. Across Pharma and Biologics platforms, they focus on innovation, operational excellence, and the highest standards of quality and compliance, driven by integrity, inclusion, accountability, and continuous improvement.
Job Summary
This 12-month contract role is within QC Strategy and Enablement department and reports to the Director of QC Lifecycle and Standardization, it supports harmonization initiatives across commercial QC laboratories. The position plays a key role in aligning analytical strategies and enabling laboratory digital systems to meet business and regulatory requirements.
Responsibilities
- Design and implement structured processes to achieve alignment and consensus on key analytical strategies across global QC laboratories, including instrumentation use and maintenance, report alignment, reconstitution practices, reagent expiry, method execution, and movement of results within QC systems.
- Lead harmonization initiatives across Commercial Pharma and Biologics QC laboratories to support digital laboratory system configuration and optimization.
- Author global procedures and supporting documentation, including training materials, training audience definition, and implementation plans.
- Maintain and manage RAID logs to support risk identification, decision-making, action tracking, and issue resolution.
- Participate in governance forums to facilitate decision-making, secure endorsement, and support effective communication of harmonization initiatives.
- Conduct gap assessments, risk assessments, and financial evaluations to support development of business cases for key analytical strategies.
- Support external benchmarking activities to ensure alignment with industry standards and best practices.
- Ensure alignment of all strategies and initiatives with regulatory expectations, health authority requirements, and filed dossiers.
- Lead with a global mindset, influencing cross-functional and geographically dispersed teams while promoting compliance, quality, and continuous improvement.
- Drive timely decision-making, issue resolution, process simplification, and efficiency improvements while modeling company values of Integrity, Passion, Inclusion, Innovation, Urgency, and Accountability.
Requirements
- Bachelor’s degree in Biological Sciences, Chemistry, or related discipline required; advanced degree in a scientific or pharmaceutical-related field (e.g., Chemistry, Pharmacy, Biology, Chemical Engineering) preferred.
- Minimum of 8 years’ experience within Quality and Compliance organizations, including direct QC experience.
- Demonstrated knowledge of commercial analytical method lifecycle management.
- Experience with analytical methods (in-process, release, stability) for late-stage or commercial products and familiarity with health authority regulations.
- Proficiency in Quality Control and Analytical processes, including cGMP/GDP regulations.
- Experience working with an EDMS in a GMP-regulated environment.
- Experience operating within cross-functional, matrixed teams and leading complex programs.
- Strong understanding of regulatory requirements, company policies, and their application to product quality investigations and documentation.
- Proven track record of delivering results, including experience supporting compliance remediation activities related to regulatory actions.
- Strategic thinker with strong business acumen and understanding of end-to-end enterprise impact.
#LI-PC2