Remedica is a globally active EU-based pharmaceutical company, headquartered in Cyprus and present in more than 110 countries. Founded in 1980, the company has evolved into a trusted generics CDMO and dossier development partner for pharmaceutical companies worldwide. Remedica combines development expertise, EU-based manufacturing capabilities, regulatory know-how and a strong quality culture to deliver competitive, high-quality medicines. Its portfolio includes over 300 products across key therapeutic areas, including cardiovascular, oncology, anti-diabetic, anti-infective, central nervous system, alimentary tract, genito-urinary and musculoskeletal treatments.

Over the last few years, Remedica went through a massive transformational program from a locally recognised reputable company to a global player, respected by its distributors, partners, and clients. The investments into the factories, R&D equipment, new facilities, implementation of best-in-class software, and people development are the baselines for Remedica's success in the future.

Job Purpose:

The Senior Data Integrity Scientist is responsible for defining, implementing, and maintaining the organisation’s Data Integrity and Data Governance strategy across GxP-regulated areas, with a primary focus on GMP operations.

The role provides senior technical and quality expertise for Data Integrity compliance, ensuring that data generated, processed, reviewed, reported, retained, and archived across the organisation are accurate, complete, consistent, attributable, legible, contemporaneous, original, and available in accordance with ALCOA+++ principles.

The Senior Data Integrity Scientist will lead the development of the Data Integrity governance framework, oversee data integrity activities & remediation of identified gaps, support inspection readiness, and provide expert guidance to all relevant stakeholders.

This position is based in Limassol. The company offers relocation support for candidates who are considering moving to Cyprus.

Duties and Responsibilities:

• Define and maintain the company’s Data Integrity and Data Governance strategy for GxP-regulated processes, systems, records, and data lifecycle activities.
• Develop, implement, and continuously improve the Data Integrity governance framework, including policies, standards, procedures, risk assessment tools, templates, and oversight processes.
• Lead cross-functional Data Integrity initiatives across GMP areas, ensuring consistent interpretation and implementation of regulatory expectations.
• Establish and maintain a risk-based Data Integrity programme, including prioritisation of systems, processes, records, and remediation activities based on patient safety, product quality, regulatory impact, and business criticality.
• Lead and oversee Data Integrity gap assessments for manual, hybrid, and electronic processes.
• Support in creation & provide expert review and approval of Data Integrity risk assessments, remediation plans, data flow maps, audit trail review strategies, user access reviews, and procedural controls.
• Identify and report Data Integrity deficiencies, establish remediation plans and ensure that corrective and preventive actions are appropriately defined, risk-based, sustainable, and completed within agreed timelines.
• Monitor progress of Data Integrity activities and escalate significant risks, delays, or ineffective actions to Quality leadership.
• Provide technical leadership on Data Integrity requirements for computerised systems, including electronic records, electronic signatures, audit trails, access controls, data backup, archival, retrieval, and system interfaces.
• Partner with CSV and IT teams to ensure Data Integrity requirements are embedded into computerised system validation, periodic review, change control, incident management, and system retirement activities.
• Define expectations for audit trail review, including risk-based review scope, frequency, responsibilities, documentation standards, and escalation pathways.
• Support inspection readiness activities related to Data Integrity, including preparation of evidence packages, mock inspections, SME coaching, and response preparation.
• Act as a Data Integrity subject matter expert during internal audits, supplier audits, regulatory inspections, and customer audits.
• Provide oversight, report and support Data Integrity-related deviations, investigations, CAPAs, change controls, and quality risk management activities.
• Develop and deliver advanced Data Integrity training and awareness programs for GxP personnel, system owners, data owners, reviewers, and approvers.
• Mentor and coach Data Integrity Scientists, Quality personnel, system owners, and process owners on Data Integrity expectations and practical implementation.
• Establish Data Integrity metrics, trend reports, governance forums, and management review inputs.
• Promote a proactive quality culture where data reliability, transparency, and ethical behaviour are embedded in daily operations. 

Qualifications and Skills:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Biotechnology, Engineering, Computer Science, Life Sciences, or a related scientific discipline
• 4+ years of experience in GxP regulated environments (pharmaceutical, biotechnology, medical device) within Quality Assurance, Validation, QC, Manufacturing, Engineering, IT Quality, or Data Integrity
• Demonstrated experience leading Data Integrity programmes, and governance initiatives.
• Experience supporting or participating in regulatory inspections involving Data Integrity topics. 
• Proven experience leading cross-functional teams and influencing stakeholders at different organisational levels. 
• Experience reviewing or approving deviations, CAPAs, change controls, validation documentation, SOPs, risk assessments, and audit trail review procedures. 
• Formal training or certification in Data Integrity, Quality Risk Management, Computerised System Validation, GxP auditing, or Quality Management Systems is desirable
• Strong working knowledge of GMP requirements and expectations for Data Integrity and Data Governance. 
• Good understanding of applicable regulatory and industry expectations (EU GMP, FDA, WHO, MHRA, PIC/S, ICH, ISPE) 
• Expert understanding of ALCOA+++ principles and practical application across manual, hybrid, and electronic data processes. 
• Strong knowledge of Data Integrity controls for manual, hybrid and electronic data
• Knowledge of regulatory expectations for manual, hybrid and electronic data and records, audit trail reviews, quality risk management, and data lifecycle controls. 
• Ability to translate regulatory expectations into practical, risk-based procedures and controls. 
• Ability to define Data Integrity requirements for new and existing systems. 
• Strong capability in quality risk management, root cause analysis, CAPA design, effectiveness checks, and remediation governance. 
• Ability to evaluate and map data lifecycle risks from data creation through processing, review, reporting, retention, and archival. 
• Skilled in developing Data Integrity policies, SOPs, standards, templates, training materials, governance dashboards, and inspection readiness packages. 
• Strong ability to interpret trail data, system logs, metadata, and data review evidence. 
• Proficient in Microsoft Office (Word, Excel, Outlook).
• Excellent Greek & English languages

Why Join Remedica?
At Remedica, we offer a competitive compensation package, including 14 salaries, a provident fund, and a range of additional benefits to support your personal and professional growth. Join our team and be part of a company that values innovation, teamwork, and continuous improvement.

Equal Opportunity Statement
At Remedica, we are committed to ensuring equal pay for equal work and work of equal value. To support this commitment, roles are evaluated using a structured, gender‑neutral job evaluation framework, which objectively assesses the knowledge, skills, responsibilities, effort, and working conditions associated with each role. This approach helps ensure fair, transparent, and consistent outcomes across the organization.

We welcome applications from all qualified candidates, regardless of sex, race, ethnicity, disability, religion or belief, sexual orientation, gender identity, or age.