This is a remote position.

CSV Quality Engineer Lead- Part-Time

Location: Remote

Commitment: Approximately 20 hours per week

Role type: Part-time

The Opportunity

A growing technology company serving pharmaceutical and other regulated manufacturing environments is seeking an experienced CSV Quality Engineer Lead.

This is a Quality leadership role responsible for establishing and maintaining the company’s quality systems and providing independent oversight of computerized system validation activities.

The CSV Quality Engineer Lead will not serve as the primary validation executor or routine software tester. Engineering, Product, and designated validation resources will create requirements, conduct testing, and produce technical evidence. This role will provide Quality governance by defining expectations, reviewing and approving validation strategies and deliverables, assessing risk, identifying compliance gaps, and confirming that systems remain in a validated and controlled state.

The successful candidate will also build and mature the company’s quality infrastructure. This includes developing SOPs, implementing document and change controls, overseeing deviations and CAPAs, establishing training and supplier-quality processes, conducting quality reviews, and preparing the organization for customer audits.

This person must be able to maintain appropriate Quality independence while partnering constructively with Engineering, Product, Operations, and leadership.

Primary Responsibilities

Quality-System Ownership

• Lead the development and continued improvement of the company’s quality management system

• Conduct a QMS gap assessment and establish a risk-based implementation roadmap

• Author, review, approve, and maintain quality policies, SOPs, work instructions, templates, and controlled records

• Establish effective processes for:

  • Document and record control

  • Change control

  • Deviations and nonconformances

  • Corrective and preventive actions

  • Risk management

  • Training and training records

  • Supplier qualification and monitoring

  • Internal audits

  • Management review

  • Periodic system review

  • Quality review of product releases

• Monitor adherence to approved quality procedures and follow up on identified gaps

• Establish meaningful quality metrics and report risks, trends, and open actions to leadership

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

CSV Quality Governance and Oversight

• Establish the company’s policies and standards for computerized system validation

• Provide independent Quality oversight of validation activities performed by Engineering, Product, suppliers, customers, or other validation resources

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

• Confirm that validation scope and evidence are appropriate for the system’s intended use, complexity, and risk

• Verify that requirements are clear, testable, approved, and traceable to suitable evidence

• Assess whether engineering and supplier testing can be leveraged as validation evidence

• Identify circumstances requiring additional verification or independent Quality review

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

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

• Ensure systems are maintained in a validated state through controlled changes, periodic reviews, and documented risk assessments

• Provide Quality approval for validation completion and regulated product releases

• Escalate material quality, compliance, and data-integrity risks to leadership

Audit and Inspection Readiness

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

• Maintain organized, complete, and inspection-ready quality records

• Support customer questionnaires, quality agreements, validation requests, and due-diligence reviews

• Represent Quality during customer audits and explain the company’s QMS and validation-governance approach

• Coordinate responses to audit observations and oversee corrective actions through closure

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

Required Experience

• At least 7 years of Quality experience in pharmaceutical, biotechnology, life-sciences technology, or another highly regulated environment

• Demonstrated experience developing, implementing, or significantly improving a quality management system

• Strong experience providing independent Quality oversight of computerized system validation

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

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

• Strong working knowledge of:

  • FDA 21 CFR Part 11

  • EU GMP Annex 11

  • PIC/S GMP expectations

  • GAMP 5

  • ALCOA+ data-integrity principles

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

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

• Experience supporting customer audits or regulatory inspections

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

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

• Reliable availability for approximately 20 hours per week

Strongly Preferred

• Experience building a fit-for-purpose QMS for a software, SaaS, IoT, laboratory technology, or life-sciences technology company

• Experience overseeing validation of systems combining software, hardware, edge devices, scientific instruments, and external integrations

• Familiarity with LIMS, MES, ELN, QMS, laboratory automation, or scientific instrument connectivity

• Experience with quality expectations in the United States, Europe, and Asia-Pacific

• Familiarity with Japan’s PMDA and other Asia-Pacific authorities operating within or aligned with PIC/S frameworks

• Experience reviewing cloud infrastructure and third-party technology providers from a Quality and validation perspective

• Ability to introduce appropriate regulatory rigor without creating unnecessary bureaucracy