Compliance and Quality Assurance Specialist

vor 2 Monaten

BadenBaden, Baden-Württemberg, Deutschland Roche Vollzeit

About the Role

We are seeking a highly skilled Quality Assurance Lead to join our team at Roche. As a key member of our organization, you will be responsible for ensuring the reliability, compliance, and risk management of our regulatory and critical IT systems.

Key Responsibilities

  • Lead a team of experts in ensuring the delivery of regulatorily sensitive systems, such as GxP, and ensure they operate according to defined policies and procedures.
  • Define and set guardrails, SOPs, policies, and frameworks in collaboration with Product Teams to enable fast decision-making and value realization.
  • Guide and monitor the IT organization on adherence to SOPs and policies, provide clear guidance and awareness on new regulatory mandates, and conduct periodic risk assessments.
  • Foster outside-in innovation, staying up-to-date with the external environment and trends.
  • Understand business compliance drivers and ensure smooth transitions between Quality Management systems of business.
  • Align Quality & Compliance framework within 2nd line of control functions in Roche Informatics.
  • Embed compliance in lean and agile processes, ensuring teams can focus on delivering compliant systems in an efficient way.

Requirements

  • 5+ years of experience as a thought leader in a relevant field, with a deep understanding of internal and external emerging GxP regulation, ITIL processes, and associated disciplines.
  • Focus on the IT market, with a passion for researching major trends and leveraging those that would be advantageous for Roche.
  • Experience building high-performing teams, based on trust, collaboration, and career development for employees.
  • Ability to lead through influence, motivation, development, and inspire employees and senior leadership at all organizational levels.
  • Focused on leading through collaboration and bringing people together to work towards the same purpose across organizational boundaries.
  • Executive presence, strong business acumen, and ability to navigate ambiguity and manage complexity.
  • Excellent communication and influencing skills, naturally engaging with stakeholders globally.
  • Fluent in English.
  • Understanding of the value of diversity in the workplace and dedication to fostering an inclusive culture.

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