Director of E2E CSV/C&Q Validation & Compliance

Source Group International

Basel-Stadt

On-site

CHF 140,000 - 190,000

Full time

48 hours ago

Be an early applicant

Application generator

A complete application in a minute — tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Source Group International in Basel-Stadt, Switzerland seeks an experienced E2E CSV/CQ Lead to define, coordinate, and deliver validation strategy for a large-scale Operations Data Hub program, ensuring compliant, risk-based validation across IT, OT, automation, data platforms, and application environments.

The role requires leading end-to-end CSV activities, strong GMP and data integrity knowledge, and collaboration with cross-functional teams to drive validation readiness and risk management

Qualifications

Bachelor's or Master's degree in Engineering, Automation, CS, IT, Life Sciences, or related field.
Proven experience leading end-to-end CSV and qualification activities across integrated IT/OT.
Fluent business-level English.

Responsibilities

Define and maintain end-to-end CSV/ qualification strategy for the ODH program.
Lead qualification and validation activities supporting production deployment.
Ensure traceability, validation evidence, testing, data integrity, and release readiness.
Collaborate with Business, Engineering, IT/OT, Quality, and external partners to deliver a unified validation package.
Align stakeholders and manage validation risks and program-level issues.

Skills

CSV/CSA leadership

GMP knowledge

ALCOA+ data integrity

Risk-based validation

Stakeholder management

Cross-functional leadership

Education

BSc/MSc in Engineering or Life Sciences

Job description

The role requires leading end-to-end CSV activities, strong GMP and data integrity knowledge, and collaboration with cross-functional teams to drive validation readiness and risk management

Get your free, confidential resume review.

or drag and drop your file here.