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Manager, QA Software Testing & Validation in Oakville at Innomar Strategies

Date Posted: 2/26/2018

Job Snapshot

Job Description


Under the general direction of the Senior Director, Quality Assurance (QA), responsibilities include (but are not limited to) providing leadership in QA testing activities at Innomar through coordination of computerized system validation activities (“GXP”), software/application testing and evaluation of software applications against design specifications and user requirements. Also to serve as the liaison between the appropriate IT teams, the operational business units and external partners (where applicable) to ensure project expectations are properly set and met. Reviews all IT projects in the pipeline and schedules the appropriate QA resource to ensure adequate allocation of QA resources for upcoming projects. Utilizes requirements traceability and risk based approaches for all development projects, and participates in requirements planning, design and execution. The Manager, QA Software Testing and Validation (STV) will manage a team of QA Analysts and Computer System Validation (CSV) Specialists.


• Responsible for identifying adequate level of Quality Assurance oversight on various IT/computerized systems.
• Help prepare and review High Level Estimates (HLEs) with IT/PM to ensure QA timelines forecasted are in sync with the expected required Project date completion required.
• Assign QA resources for all QA testing and validation activities.
• Review & provide input to the Validation Decision Tree (VDT) as submitted to QA for all new Projects as well as for any changes to validated systems.
• Coordinate and provide direct oversight of third party vendors/partners for software QA testing and/or software validation activities.
• Coordinate with the appropriate IT teams and/or third party vendors in the refinement of Business/User Requirements documentation, as well as in the preparation, development, maintenance and execution of a wide range of complex quality test plans, test cases, and test scripts with full competency of the Software Testing Lifecycle, as part of the SDLC, to ensure software meets or exceeds specified standards and end user requirements.
• Review and/or approve certain deliverables during the software testing and validation stages including: test plans, unit testing, UAT, defect lists and resolutions, summary reports etc.
• Oversee the change management process from a QA perspective including evaluating the impact of changes on both validated and non-validated systems.
• Provide QA approval on completeness of appropriate testing documentation.
• Responsible for ensuring related processes are defined within Innomar’s QMS as well as adherence to those Standard Operating Procedures (SOP’s).
• Coordinate with IT, QA and applicable business unit management in the training on testing policies, practices and tools to project team members.
• Support Innomar in hosting client and other third party audits related to the testing of computerized systems including supporting documentation.
• Provide coaching and advice on best practices surrounding Quality Assurance initiatives and acts as an ambassador of Quality.
• Participate in Quality Management Review activities including providing status updates.
• Provide performance feedback and management of direct and indirect reports.
• Oversee certain budget aspects of the QA STV team working with the Senior Director.
• Comply with all appropriate policies, procedures and safety rules and regulations.

Job Requirements


Requires a Bachelor’s Degree in a related field with a minimum of seven (7) years of experience in validation of GxP computerized systems as well as software development methodologies. Preferably with at least three (3) years in a Quality Assurance capacity, or working closely with the QA team, in a large enterprise environment with extensive integration activity and interactions with external vendors; experience with centralized, distributed and desktop applications. Familiar with documentation tools.


• Formal training in computer system software/application design and testing.
• Understanding of project management principles and methodologies with practical applied experience.
• Proven innovative leadership skills in the area of software testing and validation.
• Experience in validation of GxP computer systems is required including familiarity with PIC/S Good Practices for Computerized Systems in Regulated “GXP” Environments as well as 21 CFR Part 11 and Annex 11 EU GMP Guideline “Computerized Systems”.
• Experience in auditing of IT and validated systems is required.
• Experience in creation and review of Standard Operating Procedures (SOP’s) is required.
• Ability to use automated enterprise testing tools to support and assist company’s testing initiatives.
• Working knowledge of relevant technology, tools and software; knowledge of SDLC, Desktop services, HP Test tools, or equivalent testing tools.
• Excellent teamwork and interpersonal skills.
• Excellent leadership and relationship building skills.
• Ability to communicate effectively both orally and in writing.
• Strong analytical, problem-solving and conceptual skills.
• Excellent organizational skills; attention to detail.
• Ability to resolve system issues effectively and efficiently.
• Ability to prioritize work load and consistently meet deadlines
• Travels up to 15% of the time.