Senior Software Quality & Compliance Specialist

Responsibilities

The specialist provides independent quality and regulatory oversight for computerized systems and digital solutions within a regulated environment. They partner with IT and quality teams to evaluate SDLC practices, conduct internal audits, and manage quality risks to ensure compliance with regulatory requirements.

Requirements

Candidates must have a bachelor's degree in a relevant field and at least 5 years of experience in quality, regulatory affairs, or software validation. Proficiency in GxP, 21 CFR Part 11, and computer software assurance principles is required.

Skills

• Quality assurance
• Regulatory compliance
• Computer software assurance
• Internal auditing
• Quality management systems
• Quality risk management
• SDLC
• Data integrity
• GxP
• 21 CFR Part 11
• Validation
• Risk assessment
• Regulatory affairs
• Compliance oversight
• Stakeholder management
• Process improvement

Benefits

• Medical
• Dental
• Vision
• Life insurance
• Disability insurance
• Accident insurance
• Critical illness insurance
• Hospital insurance
• Well-being programs
• Legal services
• Identity theft protection
• Pet insurance
• Retirement plan
• Paid time off
• Holidays
• Leave plans
• Incentive plans

About this role

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. 
 

NMDP offers regular, full-time employees medical, dental, vision, life and
disability, accident/critical illness/hospital, well-being, legal, identity
theft and pet benefits. Retirement, paid time off/holidays, leave and incentive
plans are also offered to eligible employees. Please reference this link for
more information: NMDP Benefit Information
[https://www.nmdp.org/-/media/project/nmdp/nmdpsite/pdfs/external/candidate-employee-total-rewards-summary.pdf]

About NMDP

Non-profit Organizations · 1,001-5,000 employees · headquartered in Minneapolis, Minnesota · founded 1987