Senior Software Quality & Compliance Specialist

POSITION SUMMARY:

NMDP is looking for a Senior Quality & Compliance Specialist to join our Quality & Regulatory Affairs team! In this role, the Senior Quality & Compliance Specialist will provide independent quality and regulatory oversight for computerized systems and digital solutions in a regulated environment. You’ll partner closely with IT and Quality teams to evaluate SDLC practices, establish routine software auditing, assess risk, and proactively identify compliance gaps before they become inspection findings. This role is ideal for an experienced software quality professional with expertise in regulated SDLC, internal auditing, Quality Management Systems, Quality Risk Management, and Computer Software Assurance (CSA) who is comfortable challenging technical teams when testing, documentation, or controls fall short. You’ll also help strengthen the organization’s software-quality framework as it evolves toward more Agile practices and supports future AI-related software development and validation.

Additionally, this role provides quality and regulatory compliance oversight for computerized systems, digital products, data integrity controls, and software-enabled business processes operating within regulated environments. This role partners closely with Information Technology (IT), Software Quality Assurance (SQA), Product Owners, System Owners, and Business Process Owners to ensure that computerized systems are implemented, maintained, and governed in accordance with applicable regulatory requirements, quality management system (QMS) expectations, and risk management principles.
This position serves as an independent quality representative and compliance advisor. The role does not own software development, system implementation, validation execution, testing activities, or the software development lifecycle (SDLC).

ACCOUNTABILITIES:

Compliance Oversight and Assurance:

• Provide independent quality and regulatory oversight of computerized systems and digital solutions through routine internal audits
  • Evaluate whether software governance activities align with applicable 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

Quality Risk Management:

• Participate in digital and computerized system risk assessments
  • Evaluate regulatory, patient, and/or product quality risks associated with software-enabled processes and escalate as necessary
  • Ensure risk assessments appropriately consider:

o Data integrity

o Electronic records

o Electronic signatures
o Regulatory reporting impacts
o GxP process impacts
o Supplier
• Provide independent review of mitigation strategies
• Promote adoption of risk-based compliance practices

Regulatory and QMS Alignment

• Ensure internal procedures and governance models remain aligned with evolving regulatory expectations
  • Partner with process owners to incorporate compliance requirements
  • Promote application of ALCOA+ principles throughout computerized systems
  • Review proposed process changes for potential impacts to validated state of software systems
  • Participate in assessments of software suppliers and service providers
  • Support software supplier qualification and periodic evaluation processes
  • Participate/Lead quality investigations involving software-related deviations, complaints, CAPAs, audit observations, and data integrity concerns

REQUIRED QUALIFICATIONS:

Knowledge of:

• 21 CFR Part 11, 21 CFR 1271 and 211
  • Computer Software Assurance
  • Quality Risk Management (ICH Q9, ISO 14971, 9001)
  • GAMP 5 principles
  • Internal Auditing
  • Quality Management Systems

• Regulatory inspection practices

Ability to:

• Collaborate with diverse teams and influence stakeholders through excellent communication and strong interpersonal skills
  • Leverage risk-based decision-making skills to drive optimization

• Influence without authority

• Lead audits, inspections or major quality initiatives

Education and/or Experience:

• Bachelor’s degree in Science, Engineering, Quality, Computer Science, IS, Regulatory Affairs, or related field. However, upon evaluation, equivalent experience, or related education in addition to the required experience may be substituted for the specific degree requirements.
  • 5+ years in Quality, Regulatory Affairs, Compliance, Computer System Validation (CSV/CSA), Software Quality Assurance or Engineering, or related regulated industry experience.

PREFERRED QUALIFICATIONS:

• Experience working in FDA, GxP, biologics, pharmaceutical, cell therapy, blood banking, medical device or healthcare regulated environments.

Originally posted on Himalayas