The System Compliance Manager will partner with business leaders and software development team to evaluate and improve System Development Life Cycle procedures and business processes and is responsible for working with business areas to translate and prioritize high-level business requirements into detailed functional specifications and assist in the creation and upkeep of procedures, work instruction and job aid & training materials. The individual will work with business and technical resources to identify and correct defects that are detected during the testing activity. The individual will also perform verification of completion of required documentation according to company Standard Operating Procedures and Work Instruction Documents for any new systems or upgrades to the existing ones.
- Responsible to elicit business requirements from the Business Owners and assist Software Design Engineering team in converting these business requirements into user and functional requirements using various tools (mockups, etc.)
- Responsible for tracking and notifying the stakeholders of user requirement status and rationale for meeting or not meeting such requirements
- Responsible for tracking remnant requirements (based on criticality) and notifying the Software Design Engineering team for inclusion in the next release(s).
- Review and approve Software Development Lifecycle deliverables documents, including the authoring of risk assessments.
- Review of all the unit and regression testing evidence conducted during the Software Development Lifecycle to determine if software can be delivered to production for validation; as well as translate such test cases into OQ/PQ documents.
- Review of Test Traceability matrix developed by the SW team in comparison to the User Requirements.
- Prepare a risk assessment for any failed automated or manual test cases.
- Assist in improving and expanding the SDLC procedures for the SW team.
- Provide guidance to System Compliance with user requirements, testing and risk assessment for validation/qualification plans
- Conduct internal audits for SDLC procedures.
- Requires 4-year college degree in computer science or similar discipline and minimum 8 years hands-on experience in a similar capacity with SDLC procedures and system validations.
- Strong understanding of FDA regulated environments & systems validation and general knowledge of the GxPs, Annex 11 and 21 CFR P11.
- Experience in creating and reviewing SDLC related deliverables; preparing, reviewing and executing test plans; eliciting business and functional requirements; and creating traceability matrices.
Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.