Data Integrity Specialist

Summary

As our Data Integrity Specialist, you will serve as data integrity subject matter expert for a pharmaceutical manufacturing environment. The Data Integrity Specialist will be a key member of the operations team, working closely with Quality Assurance, and will ensure the integrity of electronic data for manufacturing and QC equipment supporting batch disposition activities. This role plays a critical gatekeeping function in batch disposition and is responsible for identifying discrepancies in electronic data and ensuring timely corrections and robust documentation. The Data Integrity Specialist is responsible for ensuring compliance with cGMP requirements, applicable regulations, and company policies related to data integrity. In this role, you will report to the Head of Operations.

Key Responsibilities

• Review electronic data, including system audit trails, for manufacturing and QC equipment to support batch disposition, ensuring that data integrity principles (ALCOA+) are applied consistently across all reviewed documentation.
• Identify and escalate critical and major data integrity deviations to Operations and Quality Assurance leadership and collaborate with laboratory and operations management to resolve data discrepancies.
• Author and review deviations and change requests related to data integrity.
• Create and develop operational data integrity practices in cooperation with stakeholders.
• Write, revise, review, and approve site procedures and policies related to data integrity.
• Contribute to the development of validation policies for computerized systems and ensure appropriate system maintenance in collaboration with the CS QA team and internal stakeholders.
• Participate in regulatory authority inspections (e.g. Fimea, FDA).
• Perform periodic system audit trail reviews across the site.
• Collaborate on internal audits of GMP quality systems and subsystems, with a focus on data integrity.
• Review and compile the Annual Product Quality Review (APQR).

Requirements

• Degree in a relevant field.
• Experience in the pharmaceutical or other regulated industry; knowledge of EU GMP Annex 11 and/or GAMP 5 is considered an asset.
• Knowledge of cGMP requirements, or a strong ability to rapidly adopt new regulatory requirements.
• Demonstrated ability to communicate effectively with other departments, customers, and employees at all levels of the organization.
• Demonstrated ability to make risk-based assessments requiring a strong understanding of overall site objectives.
• Demonstrated ability to work autonomously and make sound, well-justified decisions.
• Ability to resolve problems, handle conflict, make effective decisions under pressure, and conduct root cause analysis.

We offer you

• A meaningful role in an industry-leading company
• An open and relaxed working environment with highly skilled and friendly colleagues
• Encouragement and support to maintain and further develop your professional skills
• Lunch and wellbeing benefits
• Comprehensive health insurance
• The possibility to work remotely up to 50% of the week
• Flexible working hours

The position is fixed-term until the end of the year 2026, with a possibility of extension.
The salary will be based on your skills and experience and will be discussed during the recruitment process.

Interested?

For more information about the role, please contact Head of Operations Lalli Jokelainen, lalli.jokelainen@curiumpharma.com.

Please submit your CV and application letter, including your salary request, via our recruitment system by 16 April 2026 at the latest.

We’re looking forward to hearing from you!