CSV Quality Assurance Engineer

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

📋 Description

• Oversee the development and ongoing enhancement of the company’s quality management system.

• Perform a gap assessment of the QMS and create a risk-based implementation roadmap.

• Draft, evaluate, approve, and maintain quality policies, standard operating procedures (SOPs), work instructions, templates, and controlled documentation.

• Develop processes for document and record control, change control, handling deviations and nonconformances, corrective and preventive actions (CAPA), risk management, training, supplier qualification and monitoring, internal audits, management reviews, periodic system assessments, and quality evaluations of product releases.

• Monitor compliance with approved quality procedures and address any identified gaps.

• Set up quality metrics and report risks, trends, and open actions to management.

• Ensure the quality system remains practical, scalable, and appropriate for a growing technology organization.

• Develop company policies and standards for computerized system validation.

• Provide independent quality oversight of validation activities conducted by Engineering, Product, suppliers, customers, or other validation resources.

• Review and authorize validation plans, intended use statements, requirements, risk assessments, traceability matrices, test strategies, protocols, deviations, and validation summary reports.

• Ensure that the validation scope and evidence are suitable for the system's intended use, complexity, and risk.

• Confirm that requirements are clear, testable, approved, and traceable to appropriate evidence.

• Evaluate whether engineering and supplier testing can serve as validation evidence.

• Identify situations that necessitate additional verification or independent quality review.

• Examine validation deviations to guarantee they are investigated, documented, resolved, and approved.

• Verify that controls for audit trails, electronic signatures, user access, security, backup, recovery, data retention, and archiving meet relevant expectations.

• Ensure systems remain validated through controlled changes, regular reviews, and documented risk assessments.

• Provide quality approval for validation completion and regulated product releases.

• Escalate significant quality, compliance, and data integrity risks to management.

• Prepare the organization for customer audits, supplier evaluations, and regulatory inspections.

• Maintain organized, comprehensive, and inspection-ready quality records.

• Assist with customer questionnaires, quality agreements, validation requests, and due diligence reviews.

• Represent Quality during customer audits and articulate the company’s QMS and validation governance approach.

• Coordinate responses to audit findings and supervise corrective actions until closure.

• Review suppliers that could impact product quality, data integrity, regulatory compliance, or the validated state.

• Sustain Quality independence while collaborating with Engineering, Product, Operations, and management.

⛳️ Requirements

• Minimum of 7 years of Quality experience in pharmaceutical, biotechnology, life sciences technology, or another highly regulated field.

• Proven experience in developing, implementing, or significantly enhancing a quality management system.

• Strong experience in providing independent Quality oversight for computerized system validation.

• Clear understanding of the difference between validation execution and Quality review, approval, and governance.

• Experience in reviewing and approving validation plans, requirements, risk assessments, traceability matrices, test evidence, deviations, and summary reports.

• Solid working knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP expectations, GAMP 5, and ALCOA+ data integrity principles.

• Experience with document control, change control, CAPA, deviations, training, supplier quality, internal audits, and management review.

• Experience in assessing the adequacy and traceability of software testing evidence without acting as the routine software tester.

• Experience in supporting customer audits or regulatory inspections.

• Excellent technical writing, judgment, organization, and communication skills.

• Ability to work independently while fostering effective partnerships across technical and business teams.

• Reliable availability for approximately 20 hours per week.

• Strongly preferred: experience in building a fit-for-purpose QMS for a software, SaaS, IoT, laboratory technology, or life sciences technology company.

• Strongly preferred: experience overseeing validation of systems that integrate software, hardware, edge devices, scientific instruments, and external integrations.

• Strongly preferred: familiarity with LIMS, MES, ELN, QMS, laboratory automation, or scientific instrument connectivity.

• Strongly preferred: experience with quality expectations in the United States, Europe, and Asia-Pacific.

• Strongly preferred: familiarity with Japan’s PMDA and other Asia-Pacific authorities operating within or aligned with PIC/S frameworks.

• Strongly preferred: experience reviewing cloud infrastructure and third-party technology providers from a Quality and validation standpoint.

• Strongly preferred: capacity to introduce appropriate regulatory rigor without imposing unnecessary bureaucracy.

🏝️ Benefits

• Part-time commitment of approximately 20 hours per week.

• Remote work arrangement.