Senior Software Quality & Compliance Specialist

NMDP•Minneapolis, MN

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, 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 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 advises on regulatory and QMS alignment. It supports the development of the organization’s software-quality framework as it moves toward more Agile practices and considers future AI-related software development and validation. 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.

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, ISO 14971, and ISO 9001.
Knowledge of GAMP 5 principles.
Knowledge of internal auditing.
Knowledge of Quality Management Systems.
Knowledge of 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, Information Systems, Regulatory Affairs, or a related field; equivalent experience or related education in addition to the required experience may be substituted 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 risks 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 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 software supplier qualification and periodic evaluation processes.
Participate in or lead quality investigations involving software-related deviations, complaints, CAPAs, audit observations, and data integrity concerns.
Partner with IT, Software Quality Assurance, Product Owners, System Owners, and Business Process Owners to support compliant governance of computerized systems and digital solutions.
Help strengthen the software-quality framework as it evolves toward more Agile practices and supports future AI-related software development and validation.