Senior Software Quality & Compliance Specialist

🕒 October 16

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 20%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

NMDP

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1987

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

NMDP is a nonprofit organization (formerly Be The Match) that operates the national blood stem cell donor registry and coordinates cell therapy to treat blood cancers and other blood disorders. It recruits and registers donors, matches donors to patients, facilitates transplants, provides patient support and financial assistance, conducts and funds clinical research and trials, and leads advocacy and fundraising to expand access to life‑saving cell therapies.

📋 Description

• 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 computerized system controls throughout the system lifecycle • 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 consider data integrity, electronic records, electronic signatures, regulatory reporting impacts, GxP process impacts and suppliers • Independently review mitigation strategies and promote risk-based compliance practices • Ensure procedures and governance models align with evolving regulatory expectations • Partner with process owners to incorporate compliance requirements • Promote ALCOA+ principles throughout computerized systems • Review process changes for impacts to the validated state of software systems • Participate in software supplier and service-provider assessments • Support supplier qualification and periodic evaluation • Participate in or lead quality investigations involving software deviations, complaints, CAPAs, audit observations and data integrity concerns • Serve as an independent quality representative and compliance advisor; do not own software development, system implementation, validation execution, testing or SDLC activities

🎯 Requirements

• Knowledge of 21 CFR Part 11, 21 CFR 1271 and 211 • Knowledge of Computer Software Assurance (CSA) • Knowledge of Quality Risk Management, including ICH Q9, ISO 14971 and ISO 9001 • Knowledge of GAMP 5 principles • Knowledge of internal auditing • Knowledge of Quality Management Systems (QMS) • Knowledge of regulatory inspection practices • Ability to collaborate with diverse teams and influence stakeholders through excellent communication and strong interpersonal skills • Risk-based decision-making skills • Ability to influence without authority • Ability to lead audits, inspections or major quality initiatives • Bachelor's degree in Science, Engineering, Quality, Computer Science, IS, Regulatory Affairs, or related field, or equivalent experience/related education in addition to the required experience • 5+ years in Quality, Regulatory Affairs, Compliance, Computer System Validation (CSV/CSA), Software Quality Assurance or Engineering, or related regulated industry experience • Preferred: experience in FDA, GxP, biologics, pharmaceutical, cell therapy, blood banking, medical device or healthcare regulated environments

🏖️ Benefits

• Medical, dental, vision, life and disability benefits • Accident, critical illness/hospital benefits • Well-being benefits • Legal, identity theft and pet benefits • Retirement plan • Paid time off and holidays • Leave benefits • Incentive plans for eligible employees • Remote work arrangement

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume