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You will be responsible for establishing and execution of policies, processess according to international pharma standards meeting QA regulations. You will identify risk and compliance issues and drive mitigation, remediation and compliance activities within the business and IT organization.
- Supporting the information technology compliance program and providing operational leadership for IT compliance.
- Ensuring that the company meets its IT compliance obligations, working in partnership with all departments within IT and other key stakeholders in the company that include Internal Audit, Legal, Quality and HR.
- Providing leadership to ensure adherence to the organization’s IT SOPs, IT Controls framework and System Development Life Cycle (SDLC), ensuring current projects meet business and regulatory requirements.
- Act as primary contact with responsibility for responding to all IT related audits and privacy related inspections, work in collaboration with Financial SOX, and GMP related systems.
- Responsible for IT privacy initiatives to ensure that all computer-based systems comply with internal and external privacy policies and requirements.
- Responsible for response and management of IT related audit activities.
- Provide leadership in developing responses to external and internal audit findings and managing execution of mitigation activities.
- Developing and implementing processes to ensure that information systems are implemented and maintained according to corporate policies and regulatory requirements including data privacy.
- Providing guidance and oversight of computer systems quality and compliance activities, including the review and approval of compliance deliverables as appropriate.
- Supporting the organization's IT System Development Life Cycle (SDLC) ensuring that current business and regulatory requirements are satisfied. Establish a framework to monitor and audit adherence to SDLC via our stage gate process.
- Facilitate the firm-wide information security and internal audit program and help to ensure timely submission, tracking of issues, and facilitating remediation efforts
- Work with various members of the Information Protection Group to help ensure that the controls catalog is updated to reflect current risks
- Bachelor's or master's degree (computer science, information systems, business administration or related field); or equivalent work experience.
- Solid grounding and practical experience in working in the pharmaceutical environment, with experience of Compliance, CSV, Quality, IT
- Experience of GAMP 5 and working within a GxP environment.
- Good background in auditing.
- Ability to write persuasive and effective reports.
- Strong analytical skills.
- Fluent English (spoken and written).
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.