GxP Quality Control Lab Consultant

Elite Technical is seeking a GxP Quality Control Lab SMR Leader for a 6 month contract position averaging 30 hours per week. This is a fully remote opportunity after the first week of the assignment. Responsibilities include:

- Lead the design, setup, and operationalization of a new GxP-compliant Quality Control laboratory.
- Oversee day-to-day lab operations, ensuring adherence to regulatory standards (FDA, EMA, ICH).
- Develop and implement digital and automated systems to streamline QC workflows and data integrity.
- Collaborate cross-functionally with R&D, Manufacturing, and Quality Assurance to align lab capabilities with business needs.
- Recruit, train, and manage a high-performing QC team, fostering a culture of compliance and continuous improvement.

- Minimum 15 years of experience in Quality Control within GxP-regulated environments (pharma, biotech, or medical devices).
- Proven track record in setting up and leading QC labs, including equipment qualification and method validation.
- Must have SMR leadership experience within large life sciences companies. Responsible for preparing, presenting, and improving QC laboratory inputs into Senior Management Reviews, ensuring compliance with GxP expectations and driving data-driven improvements across the Quality Management System.
- Strong knowledge of regulatory guidelines (GMP, GLP, Google Cloud Platform) and quality systems.
- Experience implementing digital lab solutions (e.g., LIMS, ELN, automation platforms).
- Excellent leadership, communication, and stakeholder management skills.