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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality and Regulatory Oversight of Computerized Systems, ensuring compliance with regulatory requirements and internal procedures. Proficient in Risk-Based Decision Making and Quality Risk Management principles, with a strong focus on data integrity and software quality assurance.
Highest-signal resume keywords
Quality Risk ManagementComputer System Validation (CSV/CSA)Knowledge of 21 CFR Part 11Internal AuditingGxP Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Software Quality AssuranceRegulatory AffairsQuality Management SystemsComputer Software AssuranceRisk AssessmentMitigation StrategiesALCOA+ PrinciplesRegulatory Inspection PracticesQuality Documentation ReviewProcess Change Assessment
Soft Skills
Excellent CommunicationInterpersonal SkillsCollaborationInfluencing StakeholdersLeadership
Industry Keywords
FDAGxPBiologicsPharmaceuticalCell TherapyBlood BankingMedical DeviceHealthcare Regulated EnvironmentsISO 14971ICH Q9
Tech Stack
Tools & technologiesSDLC
About the role
Key responsibilities & impact- Provide independent quality and regulatory oversight of computerized systems and digital solutions through routine internal audits
- Evaluate software governance activities for alignment with 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
- Promote risk-based compliance practices
- Ensure internal procedures and governance models align with evolving regulatory expectations
- Partner with process owners to incorporate compliance requirements
- Promote ALCOA+ principles throughout computerized systems
- Review proposed process changes for impacts to the validated state of software systems
- Participate in assessments of software suppliers and service providers
- Support software supplier qualification and periodic evaluation
- Participate in or lead quality investigations involving software-related deviations, complaints, CAPAs, audit observations, and data integrity concerns
- Partner with IT, Quality, Software Quality Assurance, Product Owners, System Owners, and Business Process Owners
- Serve as an independent quality representative and compliance advisor; does not own software development, system implementation, validation execution, testing activities, or the SDLC
Requirements
What you’ll need- 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 of experience in Quality, Regulatory Affairs, Compliance, Computer System Validation (CSV/CSA), Software Quality Assurance or Engineering, or related regulated industry experience
- Knowledge of 21 CFR Part 11, 21 CFR 1271 and 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
- Risk-based decision-making skills
- Ability to influence without authority
- Ability to lead audits, inspections, or major quality initiatives
- Preferred: experience in FDA, GxP, biologics, pharmaceutical, cell therapy, blood banking, medical device, or healthcare regulated environments
Benefits
Comp & perks- 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