Senior Software Quality & Compliance Specialist

NMDP•Minneapolis, MN

2d•$95,000 - $115,000

About The Position

NMDP is seeking a Senior Quality & Compliance Specialist to join its Quality & Regulatory Affairs team. The role provides independent quality and regulatory oversight for computerized systems, digital solutions, digital products, data integrity controls, and software-enabled business processes in regulated environments. The specialist partners with IT, Software Quality Assurance, Product Owners, System Owners, and Business Process Owners to help ensure systems are implemented, maintained, and governed in accordance with applicable regulatory requirements, QMS expectations, and risk management principles. The position evaluates SDLC practices, establishes routine software auditing, assesses risk, identifies compliance gaps, reviews software quality documentation, and assesses whether system controls remain compliant and effective throughout the system lifecycle. It also supports alignment of internal procedures and governance models with regulatory expectations, software supplier qualification and evaluation, and quality investigations. The role is an independent quality representative and compliance advisor; it does not own software development, system implementation, validation execution, testing activities, or the SDLC. The specialist will also help strengthen the software-quality framework as it evolves toward more Agile practices and supports future AI-related software development and validation.

Requirements

Knowledge of 21 CFR Part 11, 21 CFR 1271, and 21 CFR 211.
Knowledge of Computer Software Assurance.
Knowledge of Quality Risk Management, including ICH Q9 and ISO 14971 and 9001.
Knowledge of GAMP 5 principles.
Knowledge of internal auditing, Quality Management Systems, and regulatory inspection practices.
Ability to collaborate with diverse teams and influence stakeholders through excellent communication and strong interpersonal skills.
Ability to use risk-based decision-making to drive optimization.
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 a related field; equivalent experience or related education may be substituted for specific degree requirements upon evaluation.
At least 5 years of experience in Quality, Regulatory Affairs, Compliance, Computer System Validation (CSV/CSA), Software Quality Assurance or Engineering, or related regulated-industry experience.

Nice To Haves

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

Responsibilities

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.
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.
Provide independent review of mitigation strategies and promote risk-based compliance practices.
Ensure internal procedures and governance models remain aligned with evolving regulatory expectations.
Partner with process owners to incorporate compliance requirements and promote ALCOA+ principles throughout computerized systems.
Review proposed process changes for potential impacts to the validated state of software systems.
Participate in assessments of software suppliers and service providers; support supplier qualification and periodic evaluation processes.
Participate in or lead quality investigations involving software-related deviations, complaints, CAPAs, audit observations, and data integrity concerns.
Help strengthen the organization's software-quality framework as it evolves toward Agile practices and supports future AI-related software development and validation.