Radiology (RAD) IT Risk & Compliance Manager

Bayer - Indianola, PA

Full-time

Indianola, PA

Professional, Scientific, and Technical Services

About the position

The Radiology (RAD) IT Risk & Compliance Manager at Bayer is responsible for overseeing and enhancing the Information Security Compliance Program within the Radiology IT department. This role focuses on ensuring compliance with Bayer's Information Security Standards and relevant regulatory requirements, identifying areas of non-compliance, and guiding decision-makers in developing mitigation strategies. The manager will also coordinate validation activities and collaborate with various stakeholders to maintain GxP computerized systems in a validated state.

Responsibilities

• Own the execution and improvement of the Radiology IT's Information Security Compliance Program.
• Supervise, test, and ensure compliance with Bayer's Information Security Standards and applicable regulatory requirements.
• Identify, analyze, and report on areas of non-compliance within RAD IT information systems and infrastructure assets.
• Provide guidance to decision-makers in developing mitigation strategies for non-compliance issues.
• Ensure RAD IT Controls are efficient and effective.
• Support internal and external audits.
• Maintain an issue tracking registry.
• Develop and manage corrective action plans to address non-compliance and audit findings.
• Manage remediation efforts related to CSV and Data Integrity.
• Develop and execute validation deliverables including Change control, Gap Analysis, Risk Assessments, Validation Plan, URS, FRS, IQ, OQ, PQ, UAT scripts and testing, Validation Summary Reports, and Requirements Traceability Matrix.
• Coordinate day-to-day operations of the GxP computerized system Validation activities within RAD IT.
• Collaborate and effectively manage strategic and local suppliers.
• Partner with System/Process Owners to implement and maintain GxP computerized systems in a validated state.

Requirements

• Deep technical knowledge of IT General Control design and test execution in a GxP environment.
• Confirmed experience in a Governance, Risk & Compliance (GRC) framework.
• Background applying and assessing security controls.
• Strong leadership skills with the ability to harness the dedication and contribution of team members outside of direct span of control.
• Good interpersonal and customer service skills.
• Ability to conduct and direct research into risk/compliance issues and products as needed.
• Ability to optimally prioritize and complete tasks in a DevOps environment.
• Extensive experience working in a team-oriented, collaborative environment.
• Excellent written and oral communication, problem solving, and decision-making skills.
• Working knowledge of relevant FDA, EU, ICH guidelines and regulations related to computer systems - CSV and Data Integrity.

Nice-to-haves

• Bachelor's degree and 10+ years of related work experience or equivalent combination of education and experience.
• Proven understanding of project management principles.

Benefits

• Competitive compensation and benefits programs.