In this role, you have the opportunity to
Work within a global network to address and Quality System Software Controls applicable to the US, Canada and EU related to non-product software systems
You are responsible for
- Establish lean practices around Quality System Software Controls for all shared or local QMS SW systems in line applicable policies and procedures
- Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process
- Ensure that new software and changes to existing software or infrastructures are validated before approval and use
- Ensure documentation of SW validation activities and results for all phases of the software system Life cycle including deployments and implementations.
- Defines and establishes a lean practice (tools, methods, standards, competency, process and process performance) for SW validation & lifecycle control of new and existing SW systems.
- Executes and /or manages SW validation & control activities.
- Ensures the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW applications, which automate Quality System processes.
- Authors, reviews and/or approves SW validation deliverables for non-product SW, including but not limited to SW validation plans, requirements, test plans/protocols/results, risk assessments, traceability matrix and summary reports.
- Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
- Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
To succeed in this role, you should have the following skills and experience
- 5+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.
- 5+ years of experience with IT software applications development and SDLC methodologies from requirements to validation (based on SDLC, IEEE and industry best practices)
- Expertise in validation of enterprise wide quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
- Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1.
- Demonstrated ability to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives.
- 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 apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained.
- 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 ~ 20% domestic and international.