Global Quality Systems & LIMS Manager (Remote)

Curia Global, Inc.; United States; Remote; USD 119,000 - 150,000; Full time

Benefits offered by this job

Generous benefit options (eligible on

Paid training, vacation and holidays

Career advancement opportunities

Education reimbursement

401K program with matching

Learning platform

Job summary

Curia Global, Inc. in the United States is seeking a Manager, Global Quality Systems & LIMS to lead the implementation and maintenance of the global QMS with a primary focus on LIMS across sites.

You will partner with QA, IT, and Lab teams to validate electronic systems, ensure regulatory alignment (21 CFR parts 11, 210, 211, 820) and drive continuous improvement while traveling 10–15% as needed.

Qualifications

• Minimum of 5-7 years QC experience in the pharmaceutical or biotechnology industry
• Experience in Quality Systems, with LIMS experience is a must. LabVantage experience is preferred
• Experience in QC operations as a supervisor or manager in commercial GMP QC labs
• Hands-on experience with developing, implementing, validating, and managing electronic systems (e.g., LIMS, QMS)
• Demonstrated leadership experience, both functional and cross-functional
• Strong knowledge of regulatory requirements (21 CFR Parts 11, 210, 211, 820)
• Strong change management/ implementation experience
• Minimum 2 years of managing quality laboratory systems (LIMS, ELN) in a global, multi-site, environment
• Excellent communication, time management, and organizational skills
• Experience working in a high-level collaborative environment and promoting a teamwork mentality

Responsibilities

• Lead/partner with Site QC Operations, IT and CSV on the implementation and validation of electronic solutions (primarily LIMS, but also including Quality, Document, Learning, and other electronic Management Systems) in alignment with the Global Quality strategy
• User training: provide support and training on LIMS and play a key role during hyper care implementation period
• Partner with lab subject matter experts to gather business requirements and map existing workflows to system capabilities
• Own and update LIMS Standard Operating Procedures (Global Process Owner for LIMS)
• Verify the effectiveness of Quality Systems through audits of Deviation/CAPA/CR reviews
• Lead continuous improvement of Quality Systems, such as CAPA, Deviation, Investigation, and Change Management, and direct the efforts to develop, implement, and maintain compliant and effective Quality Systems
• Responsible for developing various training programs by collaborating with the global compliance team and site teams
• Help develop framework for and participate in new site implementation of global quality systems, and routine review/upgrade of these systems
• 10-15% travel
• Other duties may be assigned

Skills

LIMS experience

Quality Systems

Leadership

Regulatory knowledge

Project management

Cross-functional collaboration

Education

B.S./B.A. or M.S. in Chemistry or Microbiology

Tools

LabVantage

LIMS

Job description

Curia Global, Inc. in the United States is seeking a Manager, Global Quality Systems & LIMS to lead the implementation and maintenance of the global QMS with a primary focus on LIMS across sites.

You will partner with QA, IT, and Lab teams to validate electronic systems, ensure regulatory alignment (21 CFR parts 11, 210, 211, 820) and drive continuous improvement while traveling 10–15% as needed.