GxP Quality Control Lab Consultant
Posted Today by 1765356289
Negotiable
Outside
Remote
USA
Summary: Elite Technical is seeking a GxP Quality Control Lab SMR Leader for a 6-month contract averaging 30 hours per week. This fully remote role involves leading the establishment and operation of a GxP-compliant Quality Control laboratory while ensuring adherence to regulatory standards. The position requires collaboration with various departments and the management of a high-performing QC team. The ideal candidate will have extensive experience in Quality Control within GxP-regulated environments and proven leadership skills.
Key Responsibilities:
- 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.
Key Skills:
- 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.
- 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.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
GxP Quality Control Lab (SMR Leader)
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.