IT Quality Audit / SDLC Specialist

We are looking for an IT Quality Audit / SDLC Specialist to support a global pharmaceutical and biotech organization operating in a highly regulated environment. The project focuses on ensuring IT quality, compliance, and audit readiness across validated computer systems for US and EU sites. The role involves close collaboration with IT, QA, and business teams to maintain compliant SDLC processes and successfully support internal and external audits.

Requirements:

• 4–6+ years of experience in IT Quality, Compliance, or GxP-related roles
• Strong knowledge of 21 CFR Part 11, Annex 11, GAMP 5, cGMP and Data Governance/Data Integrity requirements
• Solid understanding of SDLC processes in regulated environments
• Hands-on experience with CSV / CSA documentation review
• Proven experience with technical writing, risk assessments, gap analysis, change controls deviation, and CAPA management.
• Proven experience supporting internal and external IT audits
• Familiarity with Agile frameworks and tools such as Jira
• Strong technical writing and documentation skills
• Upper-Intermediate English level or higher (written and spoken)
• High attention to detail, strong organizational and problem-solving skills

Nice to have:

• Experience with MasterControl and/or TrackWise
• Previous work in pharmaceutical, biotech, or CDMO environments
• Leadership or mentoring experience

Responsibilities:

• Assist in developing and authoring global IT policies and procedures in collaboration with Global Leadership and QA teams across all Cambrex locations and departments
• Represent the Quality Management Value Stream and support client and regulatory audit activities
• Provide guidance and perform periodic reviews of validated computer systems and IT procedures
• Review CSV/CSA documentation to ensure compliance with computer system validation regulations for US and EU sites
• Oversee IT-related audit observations, coordinate audit responses, and track commitments through to resolution
• Support internal and external IT audits, including preparation of documentation, responses, and closure of findings
• Maintain and continuously improve IT quality processes, procedures, and controls
• Support risk assessments, change control, deviation, and CAPA activities
• Coordinate closely with QA and IT teams across multiple sites to ensure consistent quality and compliance practices

We offer:

• Competitive salary with the regular review 
• Vacation (up to 20 working days) 
• Paid sick leaves (10 working days) 
• National Holidays as paid time off 
• Flexible working schedule, remote format 
• Direct cooperation with the customer 
• Dynamic environment with low level of bureaucracy and great team spirit 
• Challenging projects in diverse business domains and a variety of tech stacks 
• Communication with Top/Senior level specialists to strengthen your hard skills 
• Online teambuildings