Lead, Quality Laboratory Services

Role Summary

Lead for the evaluation, implementation, and continuous improvement of laboratory technologies, workflows, and systems supporting New Product Introductions (NPIs), existing product enhancements, and lab transformation initiatives. Acts as the key liaison between QC laboratories, IT, and global functional stakeholders to drive high-impact projects. Provides subject matter expert guidance on test method validation and transfer, lab efficiency, safety, and compliance strategies while mentoring peers and championing innovation across laboratory operations.

Responsibilities

• Leads planning and execution of New Product Introductions (NPIs) within the QC laboratories including evaluation of test methods, instrumentation, lab readiness, and training strategies. Primary point of contact for new testing requests on existing products.
• Serves as the primary QC laboratory representative for cross-functional initiatives, representing QC perspectives in global teams and working with sites in the global network to ensure new test methods and/or technologies are being implemented and executed consistently across the enterprise.
• Works with the Environmental Health and Safety group and appropriate colleagues to develop and implement safety evaluations and proactive risk mitigation control strategies in alignment with regulatory and organizational standards.
• Drives continuous improvement initiatives, leveraging data-driven analysis to enhance laboratory workflows, efficiency, and system/method implementation.
• Serves as the QC subject matter expert and laboratory representative on cross-functional project teams, providing strategic direction, task delegation, and coaching to laboratory team members to ensure timely and successful project delivery.
• Arranges NPI and project support training, ensuring knowledge transfer and laboratory readiness for new and updated testing platforms.
• Conducts financial evaluations of lab initiatives, including resource planning, cost efficiency recommendations, and ROI assessments. Oversees material and equipment procurement planning, working with the procurement and finance department to ensure alignment with project timelines and budgets.
• Drives method remediation and equivalency studies ensuring scientific integrity and alignment for legacy and evolving methods.
• Manages system configuration and deployment of chromatography and laboratory information management systems to support evolving lab needs, including the development and validation of custom calculations.
• Serves as a subject matter expert in method co-validation and transfer, providing consultation to global partners and mentoring less-experienced colleagues.

Qualifications

• Bachelor‚Äôs Degree in Science, Engineering or applicable discipline.
• 7+ years‚Äô experience in a regulated or pharmaceutical Quality laboratory environment.
• Skilled in creating and executing validation and transfer protocols, method development/remediation, and managing controlled documentation.
• Ability to lead complex, multi-site or global initiatives involving diverse stakeholder groups.
• Experience in equipment procurement and project financial evaluation.
• Knowledge of laboratory informatics platforms (e.g., Empower, SampleManager, etc.)
• Strong analytical, organizational, and communication skills.
• Travel required up to 5% of the time