Testing / QA - Lead

Job Description: IT Test Lead & CMC QMS Advisor Consultant Assignment overview

CMC Digital & IT is looking for a senior consultant to support two closely connected priorities within CMC:

1. Establishing a fit-for-purpose IT test and requirements setup for an Inorigo-based application supporting analytical master data management in LIMS
2. Supporting CMC adoption of the revised corporate IT QMS processes under the RevITalize QMS programme

The consultant will operate at the intersection of IT delivery, quality, testing, compliance and operating model design . The role requires sufficient hands-on experience to establish practical ways of working while keeping the level of governance proportionate to business risk and regulatory requirements.

The assignment is particularly relevant to an environment where CMC operates a mix of classical IT applications and production-oriented IT/OT solutions , with increased standardisation and a more decentralised process architecture.

Key responsibilities Workstream 1 IT Test Lead for Inorigo application

The Inorigo platform is an existing solution used within CMC, while a new application is being implemented on top of the platform to provide better control of analytical master data used by LIMS.

The application currently lacks a sufficiently mature and structured setup for requirements management and testing. The consultant will establish a pragmatic framework that enables the implementation team to develop the solution incrementally without creating unnecessary process overhead.

Key responsibilities include:

• Define and implement a fit-for-purpose requirements and test management approach for the application.
• Establish a practical link between business/user requirements, functional specifications, risk assessment, test cases, test evidence and release approval .
• Define an appropriate test strategy covering, as relevant, functional, integration, regression, exploratory and user acceptance testing.
• Establish clear roles, responsibilities and decision points between product owner, business, IT, QA and development/test resources.
• Introduce a scalable way of working that allows the implementation team to add functionality incrementally while maintaining control and traceability .
• Assess and recommend appropriate tooling and ways of working for requirements, defects, test execution and test evidence, aligned with the surrounding Novo Nordisk environment.
• Support preparation and execution of test activities and act as the IT Test Lead towards the implementation team and stakeholders.
• Ensure that testing is risk-based and proportionate , rather than creating a heavyweight validation process for its own sake.
• Support definition of the operational setup for the application , including relevant lifecycle, change, release, support, ownership and documentation practices.
• Identify gaps and dependencies with the underlying Inorigo platform, LIMS and surrounding systems.

The expected outcome is a sustainable test and requirements setup that the team can operate independently after the assignment.

Workstream 2 CMC adoption of revised IT QMS processes

Novo Nordisk is revising its IT-related QMS and moving towards a more decentralised process architecture through the RevITalize QMS programme.

CMC will need to adopt relevant corporate/parent SOPs while determining where CMC-specific procedures, work instructions or governance are needed to address the characteristics of CMC.

The consultant will:

• Analyse the impact of revised corporate IT QMS processes and SOPs on CMC.
• Support CMC in identifying which requirements can be adopted directly , where interpretation or implementation guidance is required, and where a local CMC SOP or other procedural layer may be justified.
• Facilitate a structured gap and impact assessment across relevant CMC IT processes.
• Help distinguish requirements and operating models for:
  • classical IT applications
  • GMP computerised systems
  • production IT/OT and equipment with digital capabilities
• Translate corporate requirements into practical CMC ways of working , while avoiding unnecessary local deviations from corporate standards.
• Support definition of roles, responsibilities, interfaces and governance between CMC Digital & IT, local CMC IT teams, Enterprise IT, GMS IT, QA and business/system owners .
• Ensure alignment with relevant lifecycle, change, incident, problem, security, compliance, testing and operational management practices.
• Support the development or refinement of CMC procedures, guidance, templates and implementation material where required.
• Help prepare CMC for the practical adoption and implementation of the revised QMS processes, including stakeholder engagement and communication.
• Identify opportunities to simplify and standardise CMC IT processes rather than recreating existing enterprise or GMS capabilities locally.

A key part of the assignment is to help CMC arrive at a clear and sustainable boundary between global requirements and local CMC needs .

Expected deliverables

The consultant is expected to produce tangible outcomes, including:

Inorigo application

• A documented requirements and test management approach
• Agreed test strategy and test framework
• Traceability between requirements, risks and test evidence where appropriate
• Defined test roles and responsibilities
• Practical test planning, execution and reporting setup
• Recommendations for application operational setup, including lifecycle and change/release processes
• Coaching and handover to the implementation team

CMC QMS / RevITalize

• Impact and gap assessment of relevant revised IT QMS requirements
• Recommended adoption approach for CMC
• Clear distinction between corporate requirements and CMC-specific needs
• Recommendations on where local CMC procedures or guidance are required
• Draft/refined CMC procedures, templates or guidance where agreed
• Defined roles, responsibilities and governance interfaces
• Implementation roadmap and stakeholder engagement approach
• Handover to CMC process and operational owners

Candidate profile

We are looking for a consultant who combines strong IT quality/test management experience with practical understanding of regulated environments and IT operating models .

The ideal candidate has:

• Significant experience as an IT Test Lead, Test Manager, Validation Lead, QA IT consultant or similar role .
• Strong practical experience in requirements management, test strategy, test planning, traceability, defect management and test execution .
• Experience establishing or improving test setups for incremental/agile or product-oriented software delivery .
• Experience from pharmaceutical, life sciences or another regulated environment , preferably involving GxP and computerised systems.
• Good understanding of IT QMS, SOPs, risk management, lifecycle management, change management and operational controls .
• Experience translating corporate or global requirements into practical local processes and operating models .
• Understanding of the differences and interfaces between classical IT, GMP computerised systems and IT/OT environments .
• Ability to work effectively with both technical teams and business/quality stakeholders.
• Strong facilitation and stakeholder-management skills, including the ability to challenge existing practices constructively.
• Strong written and verbal English communication skills.

Experience with LIMS, master data, laboratory systems, Inorigo or similar information/data platforms would be an advantage, but deep Inorigo product expertise is not the primary requirement.

Experience with ServiceNow, Azure DevOps or comparable requirements/test/change-management tooling is also beneficial.

Personal characteristics

The consultant should be pragmatic, structured and quality-minded, with the confidence to operate in an environment where processes and responsibilities are evolving.

We value a person who can:

• Translate policy and quality requirements into simple, workable practices
• Apply risk-based thinking rather than bureaucracy
• Work independently while involving the right stakeholders
• Navigate across business, IT, QA and governance perspectives
• Challenge assumptions and identify unnecessary complexity
• Build consensus without losing momentum
• Coach teams and leave behind capabilities, not dependency on the consultant

Assignment context

The consultant will work closely with CMC Digital & IT, CMC business representatives, IT solution/application owners, local CMC IT organisations, QA and relevant central IT/QMS stakeholders .

The assignment covers both project delivery and process/operating-model development. The successful candidate should therefore be comfortable switching between hands-on execution, structured analysis, facilitation and advisory work .

The overall objective is to strengthen CMC\'s ability to deliver and operate IT solutions with the right level of quality, compliance and control - while preserving the speed, flexibility and decentralised ways of working needed in CMC .

Mandatory Skills:
Candidate profile

We are looking for a consultant who combines strong IT quality/test management experience with practical understanding of regulated environments and IT operating models.

The ideal candidate has:

Significant experience as an IT Test Lead, Test Manager, Validation Lead, QA IT consultant or similar role.
Strong practical experience in requirements management, test strategy, test planning, traceability, defect management and test execution.
Experience establishing or improving test setups for incremental/agile or product-oriented software delivery.
Experience from pharmaceutical, life sciences or another regulated environment, preferably involving GxP and computerised systems.
Good understanding of IT QMS, SOPs, risk management, lifecycle management, change management and operational controls.
Experience translating corporate or global requirements into practical local processes and operating models.
Understanding of the differences and interfaces between classical IT, GMP computerised systems and IT/OT environments.
Ability to work effectively with both technical teams and business/quality stakeholders.
Strong facilitation and stakeholder-management skills, including the ability to challenge existing practices constructively.
Strong written and verbal English communication skills.

Experience with LIMS, master data, laboratory systems, Inorigo or similar information/data platforms would be an advantage, but deep Inorigo product expertise is not the primary requirement.

Experience with ServiceNow, Azure DevOps or comparable requirements/test/change-management tooling is also beneficial.

Personal characteristics

The consultant should be pragmatic, structured and quality-minded, with the confidence to operate in an environment where processes and responsibilities are evolving.

We value a person who can:

Translate policy and quality requirements into simple, workable practices
Apply risk-based thinking rather than bureaucracy
Work independently while involving the right stakeholders
Navigate across business, IT, QA and governance perspectives
Challenge assumptions and identify unnecessary complexity
Build consensus without losing momentum
Coach teams and leave behind capabilities, not dependency on the consultant