Test Manager | CSV | GMP/GxP | PharmaSuite MES

Test Manager | CSV | GMP/GxP | PharmaSuite MES About the Role We are looking for an experienced Test Manager to join a long-term project within a leading healthcare organization operating in a highly regulated manufacturing environment. You will be responsible for the end-to-end testing lifecycle of PharmaSuite MES, ensuring compliance with Computer System Validation (CSV) standards and Process Requirement Specifications (PRS). This is a key role combining test leadership, quality compliance, stakeholder management, and cross-functional coordination within a GMP/GxP-regulated environment.

Key Responsibilities

• Define, maintain, and coordinate the overall testing strategy, including scope, methodology, and test sequencing

• Prepare test plans, test documentation, and final test summary reports to support regulatory and audit requirements

• Ensure testing activities comply with CSV standards and GMP/GxP requirements

• Manage testing activities within JIRA ALM and ensure traceability between test cases and PRS requirements

• Coordinate master data readiness to support testing activities and avoid delivery bottlenecks

• Oversee the execution of unit and end-to-end testing

• Coordinate the setup and scaling of test automation initiatives

• Lead project planning, facilitate meetings, and coordinate cross-functional teams

• Act as a key point of contact between Quality teams, Business Process Owners, and technical stakeholders

• Ensure testing activities are delivered in line with quality, compliance, and project objectives

Requirements:

• Proven experience in a Test Manager, Test Lead, Validation Lead, or Senior Test Engineer role

• Expert knowledge of Computer System Validation (CSV)

• Experience working within GMP/GxP-regulated environments

• Strong background in test strategy, test planning, and test execution

• Experience designing test cases and test scripts based on complex functional requirements

• Experience managing end-to-end testing activities involving multiple stakeholders

• Strong stakeholder management, communication, and coordination skills

Nice to Have:

• Hands-on experience with JIRA ALM

• Experience within the pharmaceutical or life sciences industry

• Familiarity with quality management and validation frameworks in regulated environments

• Experience working with MES platforms

• Experience with PharmaSuite MES

• Exposure to test automation initiatives

Perks and benefits:

• Comprehensive benefits - enjoy Udemy for Business, private medical care, Multisport card, veterinary package, language lessons, and shopping voucher.

• Flexibility - adaptable working hours and remote/hybrid work options to suit your lifestyle & location.

• Career growth - access opportunities for professional development and learning, including perks related to our official partnerships with global IT giants: Microsoft, AWS, Snowflake, Salesforce & more.

• Global collaboration - work with a diverse, international team.

• Innovative environment - be part of a forward-thinking and growth-oriented workplace.

• Engaging community - Work with passionate professionals and participate in team-building events, hackathons, and CSR initiatives to make an impact beyond work.

• Team-building events including our company tradition (annual company event in Mazury).

• A pleasant surprise to start your journey with us in the form of a welcome pack.

Sounds interesting? Click "Apply" and have a chance to hear more!