QMS Document Manager at F. Hoffmann-La Roche Ltd - Poland

Mississauga, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

03 Jan, 26

Salary

0.0

Posted On

05 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, Document Management, Technical Writing, Collaboration, Communication, Critical Thinking, Pharmaceutical Industry, GMP Regulations, Stakeholder Engagement, Continuous Improvement, Editing, Risk Management, Cross-Functional Teamwork, Health Authority Regulations, Process Improvement, Negotiation

Industry

Biotechnology Research

Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position **24 months - Contract Position** A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. The QMS (Quality Management System) Document Manager provides global oversight for the development and maintenance of global QMS documents. This role involves working directly with members of the Pharma Technical Network, including QMS Process Owners, document authors, Subject Matter Experts (SMEs), site/function leads, QMS compliance experts, and training personnel. The successful candidate will ensure consistent execution of the Global QMS document management process and will need strong strategic, collaboration, and communication skills to facilitate the delivery of quality documents that comply with Health Authority regulations/requirements and meet business needs. The Opportunity: You will manage the QMS document process, ensuring adherence to the overall process, architecture, and defined timelines. You will provide technical editing support to ensure writing standards are followed, as required, in conjunction with the QMS technical writer. You will maintain effective working relationships with local and global colleagues. You will continually improve the QMS process and associated tools/templates to ensure it remains effective and efficient. You will drive and contribute to continuous improvement and lifecycle management of the quality system documents (Global standard policies and procedures) with input from various sources, including stakeholder/customer/QMS process owner feedback, user input and suggestions, internal audits and health authority inspections, self-identified execution issues, changing regulations/requirements, and performance as demonstrated through metrics. You will coordinate the prioritization of the work based on risk, customer, and business need. You will communicate QMS document information to appropriate stakeholders and ensure intersections and touchpoints with other teams such as Regulatory, Training, and Inspection Management, as well as network-wide initiatives. Who you are: You will have an academic degree or equivalent and at least 5 years of experience in the pharmaceutical industry and in GMP regulated areas. You will have extensive knowledge of pharmaceutical quality systems, standards, and global Health Authority regulations. You will have experience with Quality Systems, document management, and technical writing. You will possess a network mindset as well as strong communication and negotiation skills, enabling you to establish trustful and successful relationships. You will have the ability to work effectively across multiple departments/sites and in cross-functional teams. You will be able to work accurately and adhere to schedules and timelines while handling multiple priorities. You will have critical thinking skills to make sound decisions and determine pragmatic solutions. **Relocation benefits not available for this role** Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

Responsibilities

The QMS Document Manager provides global oversight for the development and maintenance of global QMS documents, ensuring consistent execution of the Global QMS document management process. This role involves collaboration with various stakeholders to drive continuous improvement and lifecycle management of quality system documents.