Senior Software QA & Compliance Lead (Regulated)

NMDP; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

NMDP is seeking a Senior Quality & Regulatory Specialist to oversee quality and regulatory activities for computerized systems within a regulated environment. You will partner with IT and Quality teams to evaluate SDLC practices, perform internal audits, assess risk, and identify compliance gaps before inspections.

The role emphasizes CSA, QMS, GxP, and AI-related software validation, promoting ALCOA+ principles and ensuring governance aligns with regulatory expectations while supporting future

Qualifications

• Bachelor’s degree or equivalent in a relevant field and 5+ years in quality, regulatory affairs, or CSV/CSA.
• Experience with FDA/GxP environments and software quality assurance.
• Knowledge of ALCOA+ principles and data integrity requirements.

Responsibilities

• Provide independent quality and regulatory oversight of computerized systems and digital solutions through routine internal audits.
• Evaluate software governance activities against regulatory requirements and internal procedures.
• Review software quality documentation for compliance adequacy and risk-based decision making.
• Assess whether computerized system controls remain compliant and effective throughout the system lifecycle.
• Lead/participate in quality investigations involving software-related deviations, CAPAs, audit observations, and data integrity concerns.
• Support supplier qualification and periodic evaluation processes.

Skills

21 CFR Part 11

Regulatory knowledge

Quality Risk Mgmt

Internal Auditing

GxP compliance

Software Assurance

Quality Management Systems

ICH Q9

GAMP 5

Education

Bachelor’s degree in Science, Engineering, Quality, CS, IS, Regulatory Affairs, or related field

Job description

NMDP is seeking a Senior Quality & Regulatory Specialist to oversee quality and regulatory activities for computerized systems within a regulated environment. You will partner with IT and Quality teams to evaluate SDLC practices, perform internal audits, assess risk, and identify compliance gaps before inspections.

The role emphasizes CSA, QMS, GxP, and AI-related software validation, promoting ALCOA+ principles and ensuring governance aligns with regulatory expectations while supporting future