Expert IT Governance, Risk & Compliance
PM
Expert IT Governance, Risk & Compliance
IT Kontrakt powered by Avenga
Gdańsk
Type of work
Undetermined
Experience
Senior
Employment Type
B2B
Operating mode
Remote
Tech stack
GXP
ITIL
Management
Job description
Online interview
Expertise and Competencies to be Successful:
- Experience in IT internal controls, governance frameworks (e.g. ITIL, COBIT, NIST), audit, risk and compliance management, strongly preferable in pharma industry
- Knowledge of GxP, health authority regulations, computer systems validation, infrastructure qualification and ITIL processes
- Self-starter and ability to work independently
- Strong project management and analytical skills
- Strong communication and stakeholder management skills
- The Subject Matter Expert regarding any IT Governance, Risk and Compliance matters within IT
- Support IT assessments, internal and external audit and other assurance work
Governance
- Support development, implementation and maintenance of strong governance framework, risk & compliance processes
- Support implementation of IT Service Management and IT Operations processes according to ITIL/ITSM methodology
- Continuously improve the IT methodologies, standards, and internal control
- Govern and report on findings, track status, and ensure corrective actions are complete and sustainable
- Sustain purpose-driven engagement and effective interaction with Auditors, Regulators, and compliance partners.
Risk and Compliance
- Develop policies and procedures for IT Units that reflects: Legal regulations and legislations (e.g. FDA, RODO, SOX, etc.), standards and Good practices (GxP, GAMP), to ensure IT environment is fully compliant
- Support risk identification & assessments, response & mitigation, control monitoring &reporting
- Gather and evaluate information, including to support Auditors, Regulators, and compliance partners
- Develop and perform tests, to evaluate the design and effectiveness of key controls as is necessary for compliance
- Review test findings, identify control weaknesses, present results, and recommend actions to remediate issues.
- Support Computerized Systems Validation process in projects of implementation of IT solutions
- Support workforce security activities including culture, awareness and training
Other:
- IT infrastructure qualification – create qualification plan and drive retrospective qualification for existing IT infrastructure. Develop an overall strategy, standards, processes or/and procedures describing approach for qualification of newly arrived IT infrastructure components, for both local and cloud-based solutions.
- Support establishing system classification process for computerised systems