Senior Specialist, Quality Assurance

Job Summary

The Senior Specialist (Digital & Data Quality) is responsible for the quality aspects of GMP computerized systems and supporting infrastructure across site facilities, utilities, manufacturing, packaging, labeling, and laboratories. The role ensures compliance with company policies, procedures, and regulatory expectations.

• Perform quality-related activities for computerized systems required by the manufacturing division's Quality Manual or that may impact product quality, patient safety, or data integrity.
• Collaborate with stakeholders and subject matter experts from site operations, quality operations, IT, automation, and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
• Conduct independent, objective work to protect product and patient safety.
• Ensure technologies meet business needs and promote innovation and efficiency.
• Interface with Corporate Global IT and internal/external entities to align GxP shopfloor, laboratory, and quality system capabilities with quality policies and objectives.
• Oversee tailoring of initial project scope to match complexity and risk.
• Approve qualification/validation documentation, including policies, procedures, acceptance criteria, plans, protocols, specifications, reports, and changes related to computerized systems.
• Ensure at‑site and abroad system owners have operating level procedures and that systems remain validated, including problem and incident management, change control, periodic review, investigations, backup/restore, and disaster recovery.
• Review processes and documentary evidence to verify effective compliance activities.
• Support regulatory inspections and audits; review reports, respond to findings, and take appropriate actions.
• Resolve regulatory non‑conformance for GxP computerized systems.
• Communicate system health, compliance, and metrics to stakeholders.
• Promote GxP awareness and continuous improvement culture.
• Represent Digital & Data Quality management in meetings related to computerized system selection, operation, and compliance.
• Develop and maintain training programs on validation, data integrity, ALCOA principles, and system use.
• Provide quality unit review/approval of SDLC documentation.
• Mentor and guide junior team members.

• Bachelor’s degree, preferably in Science, Information Technology, Engineering, or an equivalent field.

• Hands‑on experience with automated systems supporting pharmaceutical manufacturing, IT infrastructure, and/or laboratory operations.
• Minimum 5 years in a regulated pharmaceutical manufacturing environment.
• At least 3 years delivering validated IT solutions or in an application support role in a regulated setting.
• Strong understanding of FDA, EU, and ICH regulations, especially 21 CFR Part 11, 210, 211, and 820, and local regulatory expectations.
• Extensive knowledge of computerized system validation, compliance principles, theories, and concepts.
• Experience implementing quality systems in pharmaceutical, laboratory, or biotechnology environments.
• Limited supervision required for day‑to‑day activities.

• Professional certifications (e.g., Six Sigma, PMP).
• Self‑directed team work and priority setting.
• Understanding of engineering and laboratory standards for system development, implementation, and operations.
• Quality or compliance experience in a GMP environment.
• Business engagement and collaboration with technical and non‑technical roles.
• Multilingual capabilities preferred.
• Leadership in regulatory inspections.
• Excellent oral and written communication skills.
• Analytical problem‑solving abilities.
• Listening and integrating diverse perspectives.
• Timely decision making.
• Project management with a sense of urgency and quality deliverables.
• Adaptability to changing priorities.
• Inclusive behaviors and capacity to coach and develop others.

• Adaptability
• Aseptic Operations
• Business Continuity
• cGMP Compliance
• Computer System Validation (CSV)
• Data Analysis
• Data Quality
• Disaster Recovery Planning
• Driving Continuous Improvement
• Environmental Monitoring
• GMP Compliance
• Manufacturing Process…