Redbock - an NES Fircroft company
Quality System Specialist
Redbock - an NES Fircroft company, Boston, Massachusetts, us, 02298
Lead Recruitment Consultant @ Redbock | Biotech, Medical Device and Pharmaceutical Expert
Our client is seeking two Quality Systems Specialists to support the rollout of global quality procedures and computerized systems initiatives. This role provides quality oversight across enterprise systems and ensures compliance with FDA Computer Software Assurance (CSA), ICH E6(R3) Good Clinical Practice (GCP), and data integrity standards. The ideal consultant will be a proactive quality professional with hands-on experience in computerized systems assurance, data integrity, and GxP compliance while demonstrating ability to translate regulatory guidance into practical, risk-based solutions. This is a 2-year assignment located in the Greater Boston area 3 days/week. Responsibilities
Provide quality oversight for GxP computerized systems (QMS, ERP, lab systems, Veeva, ServiceNow, ALM). Apply CSA principles to ensure system projects meet current FDA and ICH E6(R3) expectations. Participate in periodic quality review programs, vendor quality assessments, and quality agreement oversight with IT and business system owners. Support global rollout of quality procedures, data integrity mapping, and governance initiatives. Conduct or contribute to data integrity assessments and quality risk evaluations. Review documentation for computerized systems (SOPs, change controls, risk assessments). Identify quality risks, recommend mitigations, and ensure timely resolution. Participate in periodic review programs, vendor quality oversight, and audit readiness. Qualifications
Bachelor’s degree in Computer Science, Engineering, or Life Sciences. 5+ years in quality or compliance for computerized systems in GxP environments. Deep understanding of FDA CSA, ICH E6(R3), and data integrity expectations. Experience with Veeva, ServiceNow, ALM, or similar enterprise systems. Familiarity with GMP, GCP, and GLP frameworks. Strong analytical, communication, and documentation skills. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance and Consulting Industries
Biotechnology Research and Pharmaceutical Manufacturing
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Our client is seeking two Quality Systems Specialists to support the rollout of global quality procedures and computerized systems initiatives. This role provides quality oversight across enterprise systems and ensures compliance with FDA Computer Software Assurance (CSA), ICH E6(R3) Good Clinical Practice (GCP), and data integrity standards. The ideal consultant will be a proactive quality professional with hands-on experience in computerized systems assurance, data integrity, and GxP compliance while demonstrating ability to translate regulatory guidance into practical, risk-based solutions. This is a 2-year assignment located in the Greater Boston area 3 days/week. Responsibilities
Provide quality oversight for GxP computerized systems (QMS, ERP, lab systems, Veeva, ServiceNow, ALM). Apply CSA principles to ensure system projects meet current FDA and ICH E6(R3) expectations. Participate in periodic quality review programs, vendor quality assessments, and quality agreement oversight with IT and business system owners. Support global rollout of quality procedures, data integrity mapping, and governance initiatives. Conduct or contribute to data integrity assessments and quality risk evaluations. Review documentation for computerized systems (SOPs, change controls, risk assessments). Identify quality risks, recommend mitigations, and ensure timely resolution. Participate in periodic review programs, vendor quality oversight, and audit readiness. Qualifications
Bachelor’s degree in Computer Science, Engineering, or Life Sciences. 5+ years in quality or compliance for computerized systems in GxP environments. Deep understanding of FDA CSA, ICH E6(R3), and data integrity expectations. Experience with Veeva, ServiceNow, ALM, or similar enterprise systems. Familiarity with GMP, GCP, and GLP frameworks. Strong analytical, communication, and documentation skills. Seniority level
Mid-Senior level Employment type
Contract Job function
Quality Assurance and Consulting Industries
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr