Validation Lead for SAP Application - Life Sciences - Frankfurt

We are looking for people with a strong track record in Computerized System Validation (CSV) for ERP platforms such as ECC and SAP S/4HANA, along with expertise in Risk Management, and Quality Management. The role involves leading and executing validation activities for ECC to SAP S/4HANA transformation projects or SAP implementation programs for global rollouts.

You...

• Have a broad business skill set including stakeholder management, problem-solving, and resilience

• Have experience in gathering, validating, synthesizing, documenting, and communicating data and information for a range of audiences

• Have excellent interpersonal skills and strong written and verbal communication skills in country's official language(s) (C2 proficiency) and English (C2 proficiency), project-related mobility/willingness to travel

• Demonstrated capability in managing or leading multiple largescale or complex SAP S/4HANA projects, with the ability to respond effectively to evolving situations in the highly regulated Life Sciences/Pharmaceutical environment.

• Independently lead and drive validation activities through effective collaboration with clients, internal teams, and key stakeholders.

• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR Part 11, GxP, GAMP 5, Cloud, S4, Data Privacy, Data Integrity and Information Security

• Develop and document the validation strategy and approach for the Software Development Lifecycle Activities (SDLC) for the global implementation of SAP S4 HANA, consider GxP & Non GxP elements and recommend for risk-based testing approach as required.

• Work with Client Q&C to ensure system compliance with internal policies, procedures, guidelines, and applicable health authority regulations and provide improvement plans to streamline practices, and revise methodology or CSV related SOPs as necessary.

• Work with project management to build an integrated project plan inclusive of the required Computer System Validation (CSV) Lifecycle Deliverables, quality gates and summarization milestones.

• Provide leadership in critical engagements and drive successful outcomes

• Successful track record using Lean/Agile approaches to validate assets

• Ability to pursue and grow deep client relationships

• Knowledge on basic functions on SAP workstreams/modules

• Knowledge of various tools/applications used in SAP implementation program Like Solution Manager, Focused Build, CHARM, SAP GRC, SAP MDG, SAP Rise, SAP BTP, BRH, Data migration tool (SNP, ADM etc.)

• Preferable IT background to understand larger impact of architecture / technical complexities on the program

Given that this is just a short snapshot of the role we encourage you to apply even if you don't meet all the requirements listed above. We are looking for team members who strive to make an impact and are eager to learn. If this sounds like you and you feel you have the skills and experience required, then please apply now.

You want to boost your career and collaborate with expert, talented colleagues to solve and deliver against our clients' most important challenges? We are growing and are looking for people to join our team. You'll be part of an entrepreneurial, high-growth environment of 300.000 employees. Our dynamic organization allows you to work across functional business pillars, contributing your ideas, experiences, diverse thinking, and a strong mindset. Are you ready?, Be part of a globally renowned management consulting firm on the front-line of industry disruption and at the cutting edge of technology. We work with market leading brands across sectors. Our culture is inclusive and entrepreneurial. Being a mid-size consultancy within the scale of Infosys gives us the global reach to partner with our clients throughout their transformation journey., Within Europe, we are recognized as one of the UK's top firms by the Financial Times and Forbes due to our client innovations, our cultural diversity and dedicated training and career paths. Infosys is on the Germany's top employers list for 2023. Management Consulting Magazine named us on their list of Best Firms to Work for. Furthermore, Infosys has been recognized by the Top Employers Institute, a global certification company, for its exceptional standards in employee conditions across Europe for five years in a row.