Switzerland, Aargau, Kaiseraugst FHLR
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Apply now!PrintThe 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:
Reporting to the Global Head of Future ERP Program Operations, the Future ERP - Global IT Quality, Risk and Compliance Head is responsible for defining, developing and maintaining an innovative IT Quality, Risk and Compliance framework for the Roche ERP organization at the global level (including a simplified validation approach, IT controls).
The Future ERP - Global IT Quality, Risk and Compliance Head will provide governance and ensure compliance with professional standards, internal audit groups and regulatory agencies. The role is responsible for Roche ERP representation in committees and managing all audit and inspection activities that impact IT global sites, including: leading audit activities, recommending solutions to reduce risks and enhance the overall control environment with an understanding of global policy and local regulatory environmental factors, executive level communication and engagement.
The Future ERP - Global IT Quality, Risk and Compliance Head role requires developing strong partnerships and working with a variety of teams globally and locally to provide governance and oversight of internal controls and regulatory requirements.
In addition, this role will develop and execute the Roche ERP risk management plan to identify risks and evaluate the adequacy of controls to mitigate these risks and advise management on leading practice solutions and risk management issues to optimize controls in IT systems and their associated processes.
Your primary responsibilities include:
Develops and owns, leads and represents IT Quality, Risk and Compliance for Roche ERP
Roche ERP (GIS) IT Quality and Compliance Head partnering with Group Audit, PD and PT
Leads the Compliance activities for Roche ERP and in alignment with Group IT (build compliance by design)
Drives IT internal auditing and regulatory inspection activities
Develops materials and gathers control evidence to provide auditors in advance of site visits and documenting action items to closure
Year End close auditing support to Group Audit, KPMG activities
Risk Manager for Roche ERP
Develops and drives IT Quality processes for Roche ERP (GIS) IT ensuring best practices and aligned with Future ERP principles (simplification, standardization)
Auditor support role to develop auditing documentation under guidance
Scope: Audit, Inspection, and Risk Management, Computerized System Validation, Document Management, IT Training Management, ITSM, Quality Management System, Portfolio, Project, Program Management, Test Management
Qualifications:
10+ years of experience evaluating systems and process controls in a regulated industry, preferably pharmaceutical/biotech/or other related industry
Proven to lead IT quality, compliance in a CSV environment, including managing IT risks & IT audits
Strong background in relevant GxPs and relevant compliance and security standards (e.g. ISO 9000, 2700x, GxP)
Strong knowledge of LC development tools such as HPALM or HP Quality Center
Strong background in internal controls as related to system development, financial systems or FDA-related policies
Demonstrated expertise of risk analysis and audit practices
Proven track record in successfully completing projects or other assignments that have resulted in improvements in areas beyond your immediate scope and responsibilities
Highly analytical with attention to detail
Ability to travel to support audits, inspections and provide training
Proven leadership, collaboration and professionalism with internal and external stakeholders and management of all levels; ability to work effectively and efficiently in cross-functional, often virtual and matrixed team
Excellent verbal and written communication
Ability to manage multiple projects concurrently while meeting deadlines
Experience with creating materials and presenting information on complex and technical topics to a management audience.
Previous experience developing and presenting high impact presentations to Sr Management for decision-making
Previous experience leading or coordinating cross functional teams
Strong influencing, motivation and negotiation skills: proven abilities to influence others without authority
Strong management, collaboration, training and communication skills (especially at senior management level)
Good communication, project management and collaboration skills (at all levels of an organization)
People and third party management
Strong leader with excellent record tracking of team management (both direct and indirect line management)
Experience managing team to functional and budget targets
Understanding of global and corporate dynamics
Seeking accountability and driving major changes in a sustained manner