Senior Software Quality & Compliance Specialist

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Deliver autonomous quality and regulatory oversight for computerized systems and digital solutions via regular internal audits.

• Analyze software governance actions for consistency with regulatory standards and internal protocols.

• Examine software quality documentation to ensure adequacy of compliance and facilitate risk-based decision-making.

• Evaluate computerized system controls during the entire system lifecycle.

• Engage in risk assessments related to digital and computerized systems.

• Assess regulatory, patient, and/or product quality risks tied to software-enabled processes and escalate issues as needed.

• Ensure that risk assessments take into account data integrity, electronic records, electronic signatures, regulatory reporting implications, GxP process effects, and supplier considerations.

• Conduct independent reviews of mitigation strategies.

• Advocate for risk-based compliance methodologies.

• Confirm that internal procedures and governance frameworks meet changing regulatory expectations.

• Collaborate with process owners to integrate compliance requirements.

• Champion ALCOA+ principles across computerized systems.

• Assess proposed process modifications for their impact on the validated status of software systems.

• Take part in evaluations of software suppliers and service providers.

• Assist in the qualification and periodic assessment of software suppliers.

• Participate in or lead quality investigations concerning software-related deviations, complaints, CAPAs, audit findings, and data integrity issues.

• Work closely with IT, Quality, Software Quality Assurance, Product Owners, System Owners, and Business Process Owners.

• Act as an impartial quality representative and compliance consultant; does not engage in software development, system implementation, validation execution, testing activities, or the SDLC.

⛳️ Requirements

• Bachelor's degree in Science, Engineering, Quality, Computer Science, Information Systems, Regulatory Affairs, or a related field, or equivalent experience/education alongside the required experience.

• Over 5 years of experience in Quality, Regulatory Affairs, Compliance, Computer System Validation (CSV/CSA), Software Quality Assurance or Engineering, or similar regulated industry experience.

• Familiarity with 21 CFR Part 11, 21 CFR 1271, and 211.

• Understanding of Computer Software Assurance.

• Knowledge of Quality Risk Management, including ICH Q9, ISO 14971, and ISO 9001.

• Awareness of GAMP 5 principles.

• Experience with internal auditing.

• Knowledge of Quality Management Systems.

• Understanding of regulatory inspection practices.

• Capability to collaborate with diverse teams and influence stakeholders through exceptional communication and strong interpersonal skills.

• Proficiency in risk-based decision-making.

• Ability to influence without direct authority.

• Experience leading audits, inspections, or significant quality initiatives.

• Preferred: experience in FDA, GxP, biologics, pharmaceuticals, cell therapy, blood banking, medical devices, or healthcare regulated environments.

🏝️ Benefits

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Life benefits.

• Disability benefits.

• Accident benefits.

• Critical illness/hospital benefits.

• Well-being benefits.

• Legal benefits.

• Identity theft benefits.

• Pet benefits.

• Retirement plan.

• Paid time off and holidays.

• Leave benefits.

• Incentive plans for eligible employees.

• Remote work arrangement.