IT Risk and Compliance Specialist

Billennium is a Polish IT Company that has been developing innovative services and products for over 20 years and provides the best outsourcing specialists.

We implement IT projects and services in Poland and other European Union countries. We currently hire over 1600 Specialists in the field of the latest business support solutions and have offices in Poland, Malaysia, India, Germany, Switzerland, Netherlands and Canada.

Join a constantly growing team that works on projects for clients in many industries, including a global leader in the pharmaceuticals industry.

You will work in an international, innovative, and engaging environment. You will be part of a highly motivated, dynamic, and fun-loving team that is never afraid of taking on new challenges.

The Position:

Do you have a strong background in digital compliance, and have a solid quality / compliance mindset, who enjoys assess processes, systems and procedure, to evaluate their quality performance against established standards and regulatory agency guidelines? Are you looking for a creative and challenging work environment with the opportunity to expand your skills? Then the Security, Quality and Compliance Chapter is looking for you!

As an IT Risk, Audit and Compliance Specialist, you will join our diverse Informatics community and share our community values of passion, courage, integrity, and gratitude -- all in service of our mission, doing now what patients need next.

Your primary accountability is to support activities involving quality assurance and compliance, conducts internal reviews, and analyzes data / documentation. Has knowledge of commonly-used concepts, practices, and procedures for GxP environments. As an IT Risk, Audit and Compliance Specialist, you will establish strong relationships and manage stakeholders across the globe. You are someone who can negotiate and influence at all levels.

This position will be working mainly with stakeholders in Europe.

Responsibilities:

• Maintain professional expertise and up-to-date audit criteria including, but not limited to, standards / guidelines governing GxP activities, internal company policies / procedures; applicable local / international regulations (e.g., 21CFR, Eudralex Volume 4 and associated Annexes, ISO Standards, ICH, WHO, IPEC Guidelines, GDPR, HIPAA, Cybersecurity Measures, etc).
• Responsible for carrying out systematic and independent examination (also known as internal review) across various ERP systems and processes (eg. internal controls, IT policies / procedures / governances, etc.) to ensure alignment with industry standards and best practices.
• Perform due diligence assessments, review and assess the effectiveness of applicable processes and controls.
• Conduct risk assessment and gap analysis to identify potential areas of concerns.
• Provide recommendations for improvement to mitigate risks and strengthen processes.
• Collaborate with cross-functional teams to ensure observations and recommendations are addressed and resolved.
• Prepare summary reports for assigned reviews. Works with internal stakeholders to ensure observations and recommendations are clearly communicated and understood.
• Identifies and communicates opportunities for process improvement based on the observations.
• Participates in and guides process improvement activities in both small intradepartmental groups as well as complex (and possible) multidepartment interactions.
• Providing support for external audits and regulatory compliance efforts related to IT systems and data security.
• Contributing to the continuous improvement of internal review / audit processes and methodologies.
• Be a trusted partner for the business and Informatics teams and stakeholders throughout the organization.

Requirement and Qualifications:

• 8+ years' experience in a large global enterprise IT environment with experience including 2 levels: IT operations and auditing.
• Bachelor's degree (BS) in a scientific discipline, or equivalent combination of education and experience.
• Proficiency in audit methodologies, risk assessment, and control evaluation.
• A minimum of two years auditing in a GxP-regulated environment is preferred
• Excellent knowledge of GxP regulatory requirements.
• Ability to work on an international environment.
• Advance documentation skills, able to create visually appealing documentation and presentation slides
• Ability to focus on practical, common sense and sensible approaches to find effective solutions with a focus on embedding strong quality and compliance behaviors
• Excel at relationship building and networking, able to interface well with all levels of personnel
• Demonstrated ability to learn quickly in unfamiliar or ambiguous processes

Benefits:

• Hybrid working arrangement (3 days per month)
• Flexible working hours
• Work-life balance
• Health insurance coverage (including spouse and children)
• Transport allowance
• Integration activity
• Opportunities for promotion (reviewed every year)
• Professional development
• Optical coverage reimbursement
• Additional 2 days of annual leave upon completion every 1 year in Billennium.

Schedule:

• APAC Time zone (EMEA If required).
• Day shift - Fixed shift.
• Monday to Friday

If you're looking to advance your career in Workday don't miss out on applying for this role!