IT Audit Consultant – Pharmaceutical industry

We are seeking an IT Auditor whose primary responsibility is to provide leadership and expert advice on the security of our products and systems, compliance with applicable regulations, current IT security controls, secure operations, and prudent risk management.

Working closely with our stakeholders, from business partners to lawyers, procurement and security specialists, you will demonstrate your expertise in security, clinical and medical data, and build a robust framework for assessing the quality and security of our systems.

Your tasks

• Liaise between audit host managers, SMEs, auditors, and stakeholders to ensure that audit actions and remediations are documented and executed in a timely fashion

• Lead cross-functional collaborative team environments, provide innovative solutions to complex business problems

• Engage with a diverse range of stakeholders, including internal teams and external partners, on multiple concurrent global projects, across different functional areas

• Foster innovation and simplification, seeking solutions to improve and simplify existing processes, creating a culture that encourages creativity, experimentation, and continuous improvement.

• Maintain a functional level knowledge of the dynamic health authority governance around the world such as EU GDPR, MDR, CCPA, HIPAA, 21 CFR part 11, Article 11, ISO: 13485, 14971, 19011, 27001, 31000, 42001, ICH Q9, Q10

• Provide knowledge of widely recognized risk management frameworks and standards such as NIST, RMF, and COSO, COBIT and ISACA's audit and risk programs

Requirements

• Minimum 5 years of experience as an IT Auditor, and relevant certifications such as CISA, CIA, CRISC, ISO 31000 Risk Manager, ISO/IEC 27001 Lead Auditor International, or CISSP

• Strong understanding of leading security, privacy, ISO 27001, compliance, internal and external audits

• Expertise with computerized validation processes and requirements for 3rd party software and service providers in the pharmaceutical industry

• Ability to communicate efficiently complex information, issues, and potential solutions at an executive level with the use of fluent English

• Proven skills in relationship building, customer focus, decision-making, and problem-solving

• Knowledge of the adoption and use of innovative techniques

• Fluent Polish required

• Residing in Poland required