Roche

QMS Document Manager

Roche$136K — $179K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Academic degree or equivalent qualification plus 10+ years in the pharmaceutical industry and GMP environments.
  • Extensive knowledge of pharmaceutical quality systems, industry standards, and global Health Authority regulations.
  • Strong communication and negotiation skills for successful collaboration across teams.
  • Ability to manage multiple priorities and effectively work across departments and sites.
  • Strategic and critical thinking skills for risk-based decision-making and governance solutions.
  • Detail-oriented with strong project management and collaboration abilities.
  • Fluency in written and spoken English with minimal international travel required.

Responsibilities

  • Manage the end-to-end QMS document process for adherence to architecture and timelines.
  • Oversee the evolution and improvement of the QMS operating model for efficiency.
  • Maintain and enhance digital tools related to QMS documentation.
  • Lead changes for QMS Process Owners and manage onboarding programs.
  • Prioritize QMS workload based on risk assessments and business impact.
  • Build strategic collaboration across PT functions for ownership and standardization.
  • Communicate QMS updates and improvements to stakeholders proactively.

Benefits

  • Join a diverse, collaborative network in the healthcare sector.
  • Work at a global leader in addressing significant medical needs.
  • Be a part of an organization focused on quality, compliance, and operational excellence.
  • Engage in an environment that supports cutting-edge science and innovative diagnostics.
Full Job Description
The Position

At Roche, we are passionate about transforming patients’ lives. As a global leader in healthcare, we bring together cutting-edge science, innovative diagnostics, and targeted therapeutics to address some of the world’s most challenging medical needs. We believe that doing now what patients need next requires not only world-class innovation but also an unwavering commitment to quality, compliance, and operational excellence. Our Pharma Technical (PT) organization is at the heart of this mission, ensuring that our life-changing medicines are manufactured and delivered safely, reliably, and efficiently to patients worldwide. By joining Roche, you become part of a diverse, collaborative network dedicated to shaping the future of medicine.

The Opportunity

The QMS Governance team drives the delivery of PT Global QMS documents to enable effective implementation across our network. As the Global QMS Manager, you will provide global oversight for the development and maintenance of our global QMS documents, operating model, and digital tools.

In this role, your key responsibilities will include:

  • Managing the end-to-end QMS document process and coordinating cross-functional activities to ensure strict adherence to the overall QMS architecture and defined timelines.

  • Providing global oversight for the sustainment, evolution, and continuous improvement of the QMS operating model to ensure maximum efficiency and effectiveness.

  • Maintaining and improving our suite of QMS digital tools, including QMS Insights, QMS Navigator, QMS Stylus, QMS Search, and ProcessQ.

  • Leading QMS Process Owner changes, managing comprehensive onboarding programs, driving communication channels, and establishing robust performance monitoring systems.

  • Coordinating the prioritization of QMS workload based on risk assessments, customer requirements, and business impact.

  • Building and maintaining strategic collaboration and alignment across various PT functions to ensure robust ownership, standardization, and a high-performing operating model.

  • Communicating critical QMS changes, updates, and process improvements clearly and proactively to all mapped global and local stakeholders.

Who you are

You are a results-driven quality professional who thrives on collaboration, strategic thinking, and process optimization within a highly regulated global network.

To be successful in this role, you bring the following qualifications:

  • You possess an academic degree (or equivalent qualification) paired with at least 10 years of progressive experience within the pharmaceutical industry and GMP-regulated environments.

  • You demonstrate extensive knowledge of pharmaceutical quality systems, industry standards, and global Health Authority regulations, with direct experience in document control systems.

  • You bring a strong network mindset and exceptional communication and negotiation skills, enabling you to establish trustful, successful relationships with local and global colleagues.

  • You are skilled at working effectively across multiple departments, sites, and cross-functional teams while managing multiple priorities accurately within tight timelines.

  • You exhibit strategic and critical thinking skills, giving you the ability to make sound, risk-based decisions and determine pragmatic solutions to complex governance challenges.

  • You are thorough, detail-oriented, and possess strong project management and collaboration skills to successfully drive initiatives from inception to execution.

  • You are fluent in written and spoken English, possess the ability to travel internationally as needed (less than 5%), and ideally bring previous global or international work experience.

**Relocation not eligible for this position**

The expected salary range for this position based on the primary location of Mississauga is 136,936.00 and 179,728.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.

We use artificial intelligence to screen, assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

About Roche

Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the largest pharmaceutical company in the world, and the leading provider of cancer treatments globally. The company also produces a range of diagnostic tests for medical professionals and patients. Roche was one of the first companies to bring targeted treatments to patients. In 2019, Roche had over 100,000 employees worldwide, and generated revenue of CHF 61.5 billion.
Learn more about Roche
Size
100,920 employees
Industry
NASDAQ

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