Global Quality Systems Specialist – TrackWise Digital

Insud Pharma; Madrid; On-site; EUR 42,000 - 60,000; Full time

Benefits offered by this job

Flexible start time (Mon-Fri)

Permanent contract

Life and accident insurance

Ticket restaurant

On-site medical service

Benefits and Savings Club

Training and language learning support

Wellness platform and psychologist

Development plans and internal moves

Many more benefits

Job summary

INSUD PHARMA is seeking a Quality Systems Specialist in Madrid to act as a key link for Global TrackWise Digital. You’ll ensure configuration, validation, and compliance, supporting global implementations and continuous improvement across sites in line with Global Quality and IT standards.

The role covers SOP creation, validation activities, data integrity (ALCOA+), change control, and training across sites. Degree in science with 3+ years in regulated QA systems is expected.

Qualifications

• Degree in Science or related discipline; master’s degree is a plus.
• Fluent in English and Spanish; additional languages are an asset.
• Minimum 3 years in a similar Quality Systems / eQMS role in pharma or regulated industry.

Responsibilities

• Create and maintain global SOPs, work instructions, and standards related to TWD configuration and use.
• Provide configuration support for TWD modules (workflows, forms, fields, roles/permissions, notifications, reports).
• Support global rollouts/implementations, including site onboarding with local key users.
• Support the computer system validation lifecycle deliverables (URS, risk assessments, validation strategy, traceability, test scripts, evidence).
• Participate in validation of configured workflows and ensure documentation of changes and testing evidence.

Skills

Quality systems

Regulatory compliance

Training & support

ALCOA+ data integrity

Education

Science degree

Master’s degree (plus)

Tools

TrackWise Digital

Salesforce-based platforms

MS Office

Job description

INSUD PHARMA is seeking a Quality Systems Specialist in Madrid to act as a key link for Global TrackWise Digital. You’ll ensure configuration, validation, and compliance, supporting global implementations and continuous improvement across sites in line with Global Quality and IT standards.

The role covers SOP creation, validation activities, data integrity (ALCOA+), change control, and training across sites. Degree in science with 3+ years in regulated QA systems is expected.