Extelligence is an intelligent partner that goes the extra mile. We provide customized information management solutions for major industries. Our team in Prague and Bucharest is working with international companies, transforming, and adding value to their business on a daily basis. We are growing quickly, and we are interested to bring more talented individuals into our team.
- Point of contact for client stakeholders as well as Operations team for guidance & support regarding compliance control requirements and implementation into service operations
- Create & Document the control compliance plans for all services in scope
- Lead Compliance processes for large Pharmaceutical Client for specific geography
- Manages the infrastructure Qualification of hardware/Servers.
- Maintains categorization of Off-the-shelf validation categories.
- Ensure that the operations run-books & SOPs are inline & map with Policies, Standards, and Guidelines relating to security, privacy, and confidentiality for the Client IT Environment. Development of Security plan & ensuring adherence for all security domains relevant for in-scope services
- Develop & Plan internal audit calendar aligned to client’s internal as well as external audit schedule
- Execute Security audits as per the agreed upon plan with client stakeholders and work with operations teams for remediation of any gaps and non-compliances
- Provide agreed upon and ad-hoc reports for audits & compliance operations.
- Facilitate in-time evidence provisioning to client audit, risk & compliance teams at time of external audits
- Conduct process audits for ITSM as per agreed upon process controls
- Participate in client meetings and committees that investigate compliance needs and develop new and modified Policies, Standards, and Guidelines
Skills and Experience:
- Experience in Quality Management
- Accomplish ITQM objectives in the assigned project by planning, executing and evaluating quality activities (as per service description).
- Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology
- Hands-on experience in Regulatory Compliance (UK DPA, SOX, PII, Data Privacy & Security etc.).
- Should be able to liaison with the client information security, compliance & legal teams on regulatory requirements & facilitate evidence provisioning during audits
- Experience in implementation of at least 2 complete cycles of Information Security Management Systems.
- Good understanding of domains such as Network security, Firewall audits, VA/PT, Access Management etc. Should have experience in domains such as ISAE3402
- Strong knowledge of Qualification and Validation project development/implementation processes.
- Excellent FDA GxP understanding.
- Knowledge of SoX, cGMPs, FDA and EMA guidelines.
- Preferred Certifications: ISO 27000 LA, CISA, CISM, CISSP, ISO 9000
- Experience in planning & conducting & leading internal audits on information security, pharma quality & compliance
- Experience in audits of ITSM processes (Change Mgmt, Incident/Problem Mgmt). ITIL V3 foundation must.
- Good Program/Project management skills along analytics & reporting skills with strong communication & presentation.
- Ability to work with all level of clients & internal resources
- Knowledgeable about Business Continuity Management & Disaster Recovery. ISO 22301 experience preferred.
Working with Extelligence:
- We take care of the important things that matter to contractors, for example, we guarantee on-time payment for your work. You will never have to chase us for payment.
- We always seek to have long term relationships with our team and we always seek to offer opportunities to extend cooperation beyond the first contract or project.
- Extelligence is a multicultural team, we have more than 15 different nationalities working with us.
- We also organize events to bring our team together including team building activities and social events.