Future ERP - Global IT QMS and Compliance Manager

Switzerland, Aargau, Kaiseraugst

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At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. We do this today to build a better tomorrow. We are many, working as one across functions, across companies, and across the world.
The Future ERP Roadmap is a multi-year program which aims at enabling Roche to be sustainably successful in the future by streamlining and simplifying its business model and systems globally covering the following aspects:
  • Harmonizing and standardizing processes and global master data
  • Simplifying the system landscape and interfaces
  • Optimizing supply chain to realize efficiencies
  • Digitalizing and automating procurement processes

As the Global ERP IT QMS and Compliance Manager you are responsible for defining, planning and implementing strategies to ensure the regulatory, quality and validation requirements of all systems under the scope of the program are met and for the delivery of all ERP functional solutions with regards to quality and CSV aspects. You will drive the governance for the IT ICFR control framework and work with the key stakeholders in the IT functions, control owners and solution owners, as well as the internal and external audit teams. This role reports to the Global ERP IT QMS and Compliance Head.

Your primary responsibilities include:

  • Define and maintain an overall QMS and validation framework able to support the different implementation and support models for the Future ERP initiative. The QMS and validation framework must be methodology agnostic and able to accommodate any development approach or methodology used by the program, like traditional V, agile, lean, etc.
  • Define, plan and support efficient quality and validation strategies for the implementation, maintenance and retirement of all systems under the program scope, individualizing and optimizing each strategy per system and implementation project. Work closely with business and IT quality to ensure that ERP systems meet regulatory requirements and predicate rules
  • Guide the ERP implementation and supporting teams on applicable regulatory, quality, validation and compliance matters. As needed, train relevant team members on applicable regulatory, quality, validation and compliance matters and frameworks implemented
  • Own and define (as required by the validation strategies) System Risk Assessments (SRA), Data Classification Reports (DCR) and other relevant (Roche) project management methodology (i.e. PMM) deliverables. Advise project managers on risks, data privacy –GDPR- regulations, assessing the system and business risks. Provide consulting, coaching and training for various IT quality topics
  •  Assessing risk and evaluation of the design and operating effectiveness of IT general controls (ITGC) for systems and infrastructure in scope of Roche’s Internal Control Framework over Financial Reporting (ICFR)
  • Provide leadership and guidance to the IT organization on the identification and documentation of control requirements, conformance tests, control execution and monitoring procedures in order to comply with ICFR and other good practice standards

You bring the following qualifications:

  • Educated to Master’s, MBA degree level or equivalent in business or IT
  • 10+ years of experience in quality management, qualification and validation processes
  • Knowledge and proven experience with CSV, Validation and documentation environments, System Risk Assessments and Risk management and IT project management methodologies
  • Deep knowledge of IT quality and validation in large scale enterprises, excellent knowledge of ALM, knowledge of SAP, ITIL framework and ITSM processes and knowledge in Agile and Lean methodologies will be a plus
  • Drive for continuous improvement and challenge the status quo
  • Experience with IT risk management,  IT risk assessments and audits (e.g. based on ISO 27001/2 / COBIT / ITIL), both internally and externally
  • Audit certification (e.g. CISA, CIA, ISO 27001 Lead Auditor) are considered a plus 
  • Excellent leadership, collaboration and interpersonal skills in large multi-national enterprise as well as experience in delivering projects using Roche project management methodology (PMM) or equivalent
  • Proven experience in managing internal and external quality/compliance audits and C-level fluency in English and preferably conversational German
  • 12+ years of experience in a global enterprise in the Pharma industry, delivering SAP ERP solutions in transformational projects
  • 12+ years of hands on experience in delivering of 2 or more areas of SAP ERP, preferably in Pharma/healthcare industry with excellent business process knowledge in these areas
  • Experience in presenting and negotiating effectively whilst building strong partnerships
  • Outstanding communication skills are essential with the ability to communicate credibly at all levels; influence key stakeholders in a highly complex cross-functional environment and build collaborative relationships
  • Excellent leadership, management and interpersonal skills in large multi-national enterprise as well as experience in delivering IT Quality Systems, Compliance and Validation
  • Strong organizational, analytical, methodological and influential skills
  • Strong leader with excellent record tracking of team management (both direct and indirect line management)
  • Ability to capture complex problems, analyze them and translate them into solutions
  • Autonomous, structured and goal-oriented working methods and a good team player

Are you ready to apply? We are looking for someone who thinks beyond the job offered - someone who knows that this position can be a rare springboard to many other opportunities at Roche. When applying for this position, already project yourself in the future. Think about what could come next and how you wish to build your future.

Roche is an equal opportunity employer.

Quality, Quality > Quality Systems