CSV Quality Engineer

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

📋 Description

• Drive the development and ongoing enhancement of the company's quality management system.

• Perform a QMS gap analysis and create a risk-based implementation strategy.

• Draft, review, approve, and maintain quality policies, SOPs, work instructions, templates, and controlled documentation.

• Develop processes for document and record management, change control, deviations and nonconformances, CAPA, risk management, training, supplier qualification and evaluation, internal audits, management reviews, regular system assessments, and quality evaluations of product releases.

• Oversee compliance with approved quality procedures and address identified gaps.

• Set quality metrics and communicate risks, trends, and outstanding actions to leadership.

• Establish company policies and standards for the validation of computerized systems.

• Provide independent Quality oversight for validation activities conducted by Engineering, Product teams, suppliers, customers, or other validation resources.

• Evaluate and approve validation plans, intended-use statements, requirements, risk assessments, traceability matrices, testing strategies, protocols, deviations, and validation summary reports.

• Ensure validation scope and evidence are suitable for the intended use, complexity, and associated risk.

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

• Determine if engineering and supplier testing can serve as validation evidence.

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

• Review validation deviations to ensure they are investigated, documented, resolved, and approved.

• Verify that controls for audit trails, electronic signatures, user access, security, backup, recovery, data retention, and archiving satisfy applicable standards.

• Maintain systems in a validated state through controlled changes, periodic reviews, and documented risk evaluations.

• Provide Quality approval for validation completion and regulated product launches.

• Raise material quality, compliance, and data integrity concerns to leadership.

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

• Keep quality records organized, complete, and ready for inspection.

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

• Represent Quality during customer audits, articulating the company’s QMS and validation governance practices.

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

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

⛳️ Requirements

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

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

• Extensive experience providing independent Quality oversight for computerized system validation.

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

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

• Strong 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.

• Skilled in assessing the adequacy and traceability of software testing evidence without being the regular software tester.

• Experience in supporting customer audits or regulatory inspections.

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

• Ability to operate 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.