Global Quality Systems & LIMS Leader (Remote)

Curia Aalborg ApS; City of Albany (NY); Remote; USD 119,000 - 150,000; Full time

Benefits offered by this job

Generous benefits

Paid time off

Career advancement

Education reimbursement

401K with match

Learning platform

Job summary

Curia Aalborg ApS is seeking a Manager, Global Quality Systems and LIMS (Remote) to lead the implementation and maintenance of the Global Quality Management System focused on LIMS and GxP elements. You will work across sites and functions, driving electronic system projects in alignment with ICH Q10 and regulatory guidance.

Key responsibilities include training, SOP ownership for LIMS, and cross-functional collaboration with QC, IT, and CSV teams.

Qualifications

• Minimum 5-7 years QC experience in pharma/biotech
• LIMS experience required; LabVantage preferred
• QC operations supervisor/manager in GMP QC labs
• Hands-on with developing/validating electronic systems (LIMS/QMS)
• Strong knowledge of 21 CFR Parts 11, 210, 211, 820
• ≥2 years managing quality laboratory systems (LIMS/ELN) globally
• Background check and drug screen are required

Responsibilities

• Lead/partner with Site QC Operations, IT and CSV on electronic solutions (LIMS and others) per Global Quality strategy
• Provide user training on LIMS during hyper care implementation
• Map business requirements and workflows to system capabilities
• Own and update LIMS SOPs (Global Process Owner for LIMS)
• Verify effectiveness of Quality Systems via audits of Deviation/CAPA/CR reviews
• Drive continuous improvement of Quality Systems (CAPA, Deviation, Investigation, Change Management)
• Develop training programs with global compliance and site teams
• Support new site implementation of global quality systems and upgrades
• Travel 10-15%
• Other duties as assigned

Skills

Leadership

Communication

Project management

Regulatory knowledge

Problem solving

Education

Bachelor/Master in Chemistry or Microbiology

Tools

LabVantage LIMS

QMS software

Job description

Curia Aalborg ApS is seeking a Manager, Global Quality Systems and LIMS (Remote) to lead the implementation and maintenance of the Global Quality Management System focused on LIMS and GxP elements. You will work across sites and functions, driving electronic system projects in alignment with ICH Q10 and regulatory guidance.

Key responsibilities include training, SOP ownership for LIMS, and cross-functional collaboration with QC, IT, and CSV teams.