At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.
Radiology (RAD) IT Risk & Compliance Manager
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Radiology (RAD) IT Risk & Compliance Manager are to:
This role will own the execution and improvement of the Radiology IT's Information Security Compliance Program. The primary focus of this role will be to supervise, test and ensure compliance to Bayer's Information Security Standards as well as applicable regulatory requirements. They will identify, analyze, and report on areas of non-compliance within RAD IT information systems and infrastructure assets and provide guidance to decision-makers with development of mitigation strategies. They will ensure that adequate and effective security processes and controls are followed and aligned to deliver compliance.
Ensure RAD IT Controls are efficient and effective;
Support internal and external audits;
Maintain Issue tracking registry;
Develop and be responsible for 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, but not limited to, 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 and adhere to Data Integrity principles in accordance with external regulatory expectations and internal requirements.
WHO YOU ARE
Bayer seeks an incumbent who possesses the following:
Required Qualifications:
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, ability to harness the dedication & contribution of team members outside of direct span of control;
Good interpersonal skills and customer service skills;
Ability to conduct and direct research into risk/compliance issues and products as the need arises;
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.
Preferred Qualifications:
Bachelor's degree and 10+ years of related work experience or equivalent combination of education and experience;
Proven understanding of project management principles.
This posting will be available for application until at least 11/14/2024.
YOUR APPLICATION
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Bayer is an E-Verify Employer.
Location: United States : New Jersey : Whippany || United States : Pennsylvania : Indianola
Division: Enabling Functions
Reference Code: 832754
Contact Us
Email: ***
Job Segment: Compliance, Information Security, Radiology, Law, Information Systems, Legal, Technology, Healthcare
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