Quality assurance specialist Jobs in Staufen im Breisgau

The Position

Quality Assurance Lead

Throughout our 125-year history, Roche has grown into one of the world’s largest biotech companies and a global supplier of transformative innovative solutions across major disease areas.

At Roche, we believe every employee makes a difference. We are passionate about transforming patients’ lives. We are confident in both decision and action, we believe that good business means a better world.

As a Quality Assurance Lead , you will be accountable for ensuring that Roche’s regulatory and critical IT systems are reliable, compliant and meet acceptable risk standards. You will continuously evolve and improve Roche Informatics as an organization and be a trusted partner of innovations in Quality management.

You will lead the IT Quality strategies, role model lean thinking, and strive for streamlined, simplified processes, leveraging on digitalized technologies, automation, AI, Cloud, data analytics, quality by design approach, and implementation of a risk-based approach.

You will promote networked, agile ways of working, using creative leadership (Visionary, Architect, Catalyst and Coach) to unleash the potential of your team members and create an environment that fosters a great culture, a strong sense of belonging, personal growth, sharing and trust.

Your key responsibilities :

Leading a team of experts, providing independent oversight of delivery for regulatorily sensitive systems eg GxP, and ensuring the systems / products operate according to the defined policies and procedures.

Defining and setting guardrails, SOPs, policies, and frameworks in close collaboration with Product Teams to enable fast decision-making and value realization.

Guiding and monitoring the IT organization on adherence to the SOP and policies, ensure adoption, provide clear guidance and awareness on new regulatory mandates, and conduct periodic risk assessments.

Fostering outside-in innovation, staying up to date with the external environment and trends.

Understanding the business compliance drivers and ensuring there are smooth transitions between Quality Management systems of business.

Aligning Quality & Compliance framework within 2nd line of control functions in Roche Informatics.

Embedding compliance in the lean and agile processes, ensuring teams can focus on delivering compliant systems in an efficient way.

Your qualifications and experience :

You have around 5 years of demonstrated experience as a thought leader (in relevant field) with deep understanding of internal and external emerging GxP regulation, ITIL processes and associated disciplines.

You are focused on the IT market, have a passion for researching major trends and leveraging those that would be advantageous for Roche.

You have experience building high-performing teams, based on trust, collaboration, and career development for employees.

You are able to lead through influence, motivation, development, and inspire employees and senior leadership at all organizational levels.

You are focused on leading through collaboration and bringing people together to work towards the same purpose across organizational boundaries.

You demonstrate an executive presence, strong business acumen, and ability to navigate ambiguity and manage complexity.

You possess excellent communication and influencing skills, naturally engaging with stakeholders globally.

You’re fluent in English.

You understand the value of diversity in the workplace and are dedicated to fostering an inclusive culture in all aspects of working life so that people from all backgrounds receive equal treatment, realize their full potential, and can bring their full, authentic selves to work.

What you get :

Good and stable working environment with attractive compensation and rewards package (according to local regulations);

Full time employment contract;

Annual bonus payment based on performance;

A dedicated training budget (training, certifications, conferences);

Access to various internal and external training platforms Linkedin Learning);

Experienced and professional colleagues and workplace that supports innovation;

Multiple Savings Plans with Employer Match

Company’s emphasis on employees’ wellness and work-life balance ( generous vacation days and OneRoche Wellness Days ),

Workplace flexibility policy;

State of art working environment and facilities;

And many more that the Talent Acquisition Partner will be happy to talk about!

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