The Director Software Compliance and Control is the leader for ensuring regulated automated tools used in the Quality System are appropriately validated and controlled through their life cycle from development, deployment, change control and retirement. This includes implementing the required processes and control mechanisms for software, hardware, data and relevant security to meet regulatory requirements. This role will ensure appropriate representation of these activities during external regulatory assessments such as FDA, notified bodies or by other government authorities world-wide.
Watch: Career Advice
In this role you will be challenged to:
· Creatively architect validation policies and procedures that meet compliance requirements while facilitating business needs and balancing risk
· Contribute to shaping the short and long-term information technology strategies aligned with company business objectives with an intent to provide Philips with a global competitive advantage
· Drive change through influence in a globally diverse, matrix organization
· Manage a diverse set of projects and priorities ensuring your team resource and risk trade-offs are appropriate balanced
Your Responsibilities:
· Establish and implement policies and procedures for Software Validation Life Cycle control for use in Healthcare across all automated processes that drive, interface with, and provide data for the Quality System.
· Provide strategy, leadership and direct management for software validation activities to ensure validation deliverables are compliant, consistent and accessible
· Ensure proper cross-functional and cross-business organizational controls are in place to maintain the validated state of relevant software, hardware, data and security from development and release to production through ongoing maintenance/change control until retirement
· Recruit, hire and retain talent with the necessary skill sets to build a software quality assurance capability leverage able across Philips Healthcare
· Collaborate with IT and Q&R leaders across Healthcare to drive common understanding of regulatory requirements for software validation and any other aspects of IT having regulatory implications
· Subject matter expert on regulatory requirements and GAMP (Good Automated Manufacturing Processes) and the communication and training of these requirements to relevant functional and business partners
· Strategic driver across Philips for coordinating requirements for software/hardware, data and security controls in non-Healthcare sectors having medical device product portfolios
· Represent Philips Healthcare during external regulatory assessments for requests related to the validation of software/hardware fitness for intended use including relevant security and data controls
Requirements:
· Bachelor’s degree in Computer Science and advanced degree in Information Technology or MBA
· Certification Project Management desired
· Minimum 10 years’ experience in validation of computer systems and systems security and control including supervision of a technical professional staff
· Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5
· Demonstrated ability to interact and communicate (both oral and written) with a broad employee base including business leaders and senior executives.
· Expertise in IT protocols related to software/hardware validation, information security, data lifecycle management
· Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
· Ability to work across cultures and regions of the world
· Effective judgment and decision making skills, typically made under stressful situations
· Competency in project management and the execution of multiple projects
· Demonstrated capability in critical thinking and leadership with strong abilities in relationship management
· Ability and willingness to travel ~ 40% domestic and international
· Fluent in English
Send To A Friend
Posts
