Digital QA Manager - GMP/CSV & Digital Systems

Guerbet; Raleigh (NC); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Personal development opportunities

Diversity and inclusion initiatives

Job summary

Guerbet is looking for a Digital Quality Assurance Manager in Raleigh, North Carolina. This role involves providing quality oversight and governance for digital quality systems within a GMP-regulated environment. You'll be responsible for ensuring compliance, data integrity, and leading digital transformation initiatives.

The ideal candidate has over 8 years of experience in quality assurance, a strong understanding of regulatory requirements, and a passion for improving processes and efficiency.

Qualifications

• 8+ years of experience in pharmaceutical manufacturing or quality assurance.
• Strong working knowledge of CSV/CSA and regulatory compliance.
• Demonstrated ability to manage complex digital initiatives.

Responsibilities

• Provide Quality oversight for computerized systems in GMP environments.
• Establish Data Integrity governance adhering to ALCOA+ principles.
• Lead risk assessments related to data integrity issues.

Skills

Quality oversight for computerized systems

Data Integrity governance

Leading digital transformation initiatives

Regulatory inspection knowledge

Education

Bachelor's degree in Life Sciences, Engineering, or related discipline

Tools

eQMS

LIMS

Job description

Guerbet is looking for a Digital Quality Assurance Manager in Raleigh, North Carolina. This role involves providing quality oversight and governance for digital quality systems within a GMP-regulated environment. You'll be responsible for ensuring compliance, data integrity, and leading digital transformation initiatives.

The ideal candidate has over 8 years of experience in quality assurance, a strong understanding of regulatory requirements, and a passion for improving processes and efficiency.