Data Integrity Sr. Specialist – Pharmaceutical Operations

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

The Data Integrity Sr. Specialist ensures total compliance with data integrity regulations across all manufacturing. This role provides strategic oversight to guarantee that all data conforms strictly to ALCOA+ principles.

Key Responsibilities 

ALCOA+ Oversight & Compliance

• Attributable: Enforce unique user documentation in all related GXP raw data.
• Legible: Guarantee systems & oversight that maintain all records and paper printouts remain readable for the entire lifecycle.
• Contemporaneous: oversight real-time data recording protocols for related manufacturing activities and workflows.
• Original: Establish secure metadata archiving to preserve original inputs and true copies.
• Accurate: Standardize system calibrations, source verification steps, and robust audit trail / traceability reviews.
• Complete: Audit all generated data, including all related GXP records.
• Consistent: Align cross-functional steps to ensure chronological sequencing of all application event logs.
• Enduring: Maintain media storage standards to prevent data degradation over decades-long retention periods.
• Available: Optimize retrieval systems for immediate access during regulatory inspections. 

Strategy & Governance

• Policy Design: oversight global data integrity policies implementation mirroring WHO, EMA, and MHRA guidelines.
• Risk Management: Lead Data Integrity Risk Assessments (DIRA) to identify gaps in GXP systems.
• Audit Defense: Serve as the subject matter expert during regulatory inspections and corporate audits via routine Gemba walks.
• Remediation Tracking: Manage corrective and preventive action (CAPA) plans for system vulnerabilities to enhance & improve DI & Quality GXP staff mindset
• Culture Leadership: Run continuous corporate campaigns promoting an open, transparent data integrity culture. 

Qualifications and Experience:

• Regulations: Deep mastery of 21 CFR Part 11, EU GMP Annex 11, and GAMP5 frameworks
• Bachelor’s degree in pharmacy, Chemistry. 
• 4-7 years of experience in a similar position & responsibilities in pharmaceutical manufacturing organization.
• Minimum of 3 years in dedicated data integrity, QA IT, or compliance leadership role.
• Proven track record working within multinational matrix organizations.
  
• Excellent communication in English language is a must.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!