Associate Director Engineering (E2E CSV/C&Q Lead)

E2E CSV/C&Q Lead

We are seeking an experienced E2E CSV/C&Q Lead to define, coordinate, and deliver the integrated qualification and validation strategy for a large-scale Operations Data Hub (ODH) program. This role will ensure a compliant, risk-based, and scalable validation approach across interconnected IT, OT, automation, data platform, and operational application environments.

Key Responsibilities

Validation Strategy & Governance

• Develop and maintain the end-to-end CSV/C&Q strategy for the ODH program.
• Define intended use, GxP boundaries, system classification, and validation principles across source systems, integrations, platform services, data products, and applications.
• Establish reusable validation frameworks and qualification approaches for current and future deployments.
• Ensure validation deliverables are complete, consistent, and ready for Quality review and approval.

Qualification & Validation Delivery

• Lead and coordinate qualification and validation activities supporting production deployment.
• Ensure end-to-end traceability, validation evidence, testing, data integrity, and release readiness.
• Collaborate with Business, Engineering, Automation, IT/OT, Quality, and external partners to deliver a unified validation package.
• Drive validation readiness assessments and support operational release decisions.

Data Integrity & Traceability

• Define validation approaches for data products and operational applications.
• Ensure full traceability from business requirements through source systems, integrations, semantic models, platform services, and user-facing applications.
• Verify data integrity, ALCOA+ compliance, auditability, and data lineage across integrated environments.

Supplier Assurance & Quality Compliance

• Define supplier assurance, testing reliance, and qualified component reuse strategies.
• Partner with IT and OT Quality teams to ensure alignment with GMP, CSV/CSA, C&Q, change control, CAPA, and validated-state maintenance requirements.
• Support a pragmatic, risk-based validation approach that balances compliance and operational efficiency.

Cross-Functional Leadership

• Align stakeholders across Business, Quality, IT, OT, Automation, Architecture, and Engineering teams.
• Facilitate risk assessments, intended-use evaluations, and validation decisions.
• Proactively manage validation risks, dependencies, and program-level issues.
• Develop validation blueprints, qualification archetypes, and rollout models for future deployments.

Requirements

• Bachelor's or Master's degree in Engineering, Automation, Computer Science, Information Technology, Life Sciences, Pharmaceutical Sciences, Quality Management, or a related field.
• Strong experience leading end-to-end CSV and qualification activities across integrated IT/OT environments.
• Deep knowledge of GMP, CSV/CSA, C&Q, data integrity, ALCOA+, risk-based validation, and quality systems.
• Experience with automation systems, MES, historians, enterprise applications, integrations, and data platforms.
• Proven ability to manage requirements, traceability, risk assessments, testing strategies, and validation documentation.
• Strong stakeholder management and cross-functional leadership skills.
• Fluent business-level English.

This is an excellent opportunity for a validation professional who can drive a pragmatic, compliant, and scalable validation framework while enabling future growth and deployment across a global operational landscape.