Senior Manager, QA Software Testing & Validation
Job Description

Are you looking to make a difference in a patient’s life?  At AmerisourceBergen, you will find an innovative culture that is patient focused and dedicated to making a difference.  As an organization, we are united in our responsibility to create healthier futures.


As a pivotal member of the Innomar Quality Assurance (QA) management team, the Senior Manager, QA Software Testing & Validation (STV) responsibilities include (but are not limited to) providing leadership to the entire Innomar enterprise around QA for digital solutions through the 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 Senior Manager, QA Software Testing & Validation (STV) will manage a team of QA Analysts and Computer System Validation (CSV) Specialists and reports to the Senior Director, QA Services.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Responsible for ensuring Innomar’s compliance to regulations, client requirements and Innomar’s internal procedures for software testing and validation (STV);
  • Direct the organizational STV policies and procedures and work closely with other stakeholders (e.g. IT) to ensure Innomar’s processes are established and compliant;
  • 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;
  • Responsible for ensuring related processes are defined within Innomar’s QMS as well as adherence to those Standard Operating Procedures (SOPs);
  • 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 STV initiatives and acts as an ambassador of Quality; 
  • Participate in Quality Management Review activities including providing status updates as requested;
  • Provide performance feedback and management of direct and indirect reports;
  • Support the budget process with the Senior Director, QA Services, to prepare the QA budget and manage departmental expenses;
  • Work with the rest of the QA management team in the development/revision and implementation of QA policies and procedures as required;
  • May also be assigned other duties and tasks as required from time to time by the Senior Director, QA Services.




EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
 

Requires a Bachelor’s Degree in a related field with a minimum of ten (10) years of experience in a GxP environment. Preferably with at least five (5) years in a Quality Assurance management capacity in a large enterprise environment with extensive integration activity and interactions with external vendors. Minimum of five (5) years in the validation of GxP computerized systems as well as software development and testing methodologies.

 
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
  • Expert knowledge of Health Canada Food and Drugs Regulations and other pertinent industry regulations and associated guidelines around computerized systems;
  • Expert knowledge in software testing methodologies such as waterfall or agile etc.;
  • Understanding of project management principles and methodologies with practical applied experience; 
  • Proven innovative leadership skills in the area of software testing and validation;
  • Expertise 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 (SOPs) 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;
  • Proven conflict management skills with the ability to provide leadership to others in response to situations and to escalate more critical decisions when relevant;
  • Excellent verbal and written communication skills, work well in an interdependent team environment, and promote positive, respectful professional relationships. Proficient in writing reports containing technical information;
  • Effective presentation skills and experienced in the development of training courses and materials;
  • Proven ability to organize individual and team workload, set priorities and multi-task in order to meet various competing work deadlines, yet being flexible, adaptable and able to respond to changing needs;
  • 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.



 

We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.

  • Competitive compensation packages
  • Comprehensive health and dental plans
  • Flexible & remote working options
  • Employer RRSP-matching
  • Online peer-to-peer recognition program
  • Corporate discounts with multiple establishments, including fitness centers
  • Health & Wellness program with onsite yoga and massage therapy





AmerisourceBergen is a publicly traded Fortune 10 global healthcare solutions company and is one of the world's largest pharmaceutical services companies. Powered by our associates around the world, we provide pharmaceutical products and business solutions that improve access to care.  We operate the backbone of the healthcare supply chain. We drive the future of local care delivery.  We guide medical innovations to market.  We create healthier futures.



Job Requirements

 

Company Overview

Innomar Strategies was founded in 2001 around the kitchen table of our current president, Guy Payette, and his partners. The company originally specialized in market access and reimbursement consulting, and gradually expanded its capabilities to include fully integrated patient support programming, nursing support, and specialty logistics. By the end of 2008, the company had grown to have over 450 associates.

In 2009, AmerisourceBergen acquired Innomar Strategies further establishing the company’s expertise in specialty pharmaceuticals. As part of AmerisourceBergen, Innomar Strategies is connected with a global leader in healthcare with over $135 billion of annualized revenue and 18,000 associates. AmerisourceBergen has an established history of delivering innovative programs and solutions across the pharmaceutical supply channel.

With over 1,200 associates and a nationwide footprint, Innomar Strategies is Canada’s leading service provider to specialty pharmaceutical and biotech manufacturers. Innomar is differentiated by their Integrated Service Model, which provides customized solutions to improve product access, increase supply chain efficiency, and enhance patient care. Manufacturers trust Innomar Strategies to deliver innovative brand solutions throughout the product lifecycle.