Operations Quality QSE Chapter Technical Lead

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The Position

At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

As an Operations Quality QSE Chapter Technical Lead, you are responsible for ensuring Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is every patient’s right and every employee’s responsibility.  This opportunity presents an attractive prospect for you to work on topics with substantial exposure. You will collaborate closely with senior management, influencing decision-making processes and playing a pivotal role in shaping the organization's quality landscape. As a QSE Chapter Technical Lead you are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other and the We@Roche Diagnostic Commitments.

The Opportunity

• You are a strategic business partner that applies new approaches to break down silos between organizations (internal and external) all of which lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle. You push the boundaries to enable and implement smart, risk-based compliant processes that result in quick and efficient innovation.

• You are accountable for the architecture of your certified quality system, performing the quality planning activities, identifying risks, collaborating, communicating,  and influencing senior management to ensure we implement the mQMS and continue to deliver execution of our processes effectively. This includes coordinating, executing, and leading Management Review and Routine Execution Monitoring, ensuring the organization understands the risks and that we have actions to ensure continuous control of our processes, maintaining our right to operate. 

• You communicate with authorities and internal stakeholders to prepare, lead and follow up on external inspections. As a launch manager, you are responsible for the effectiveness of the modular QMS. You work closely with the Management Representative and the Executive Leadership, understanding the strategy, at the site to ensure Management Responsibility is effective in the management of our quality system. 

• You perform activities as required to meet Q&R goals and objectives independently and lead through the performance of these activities.   You are responsible for training, coaching,  mentoring and leading other quality managers or business partners, and have a deep product and process understanding and are able to translate this understanding into tangible learnings for other employees. 

• You implement overarching strategies to shift the focus from compliance only related product quality activities to proactive quality focused product quality activities.  You support a mindset of creativity and experimentation to enable Operations Quality to be a true trailblazer and support radical simplification as well as continuous improvement.

• You break down silos and improve working effectiveness as an ‘integrator’ across the organization as needed; in particular through collaboration  with other Networks, Chapters and stakeholders to resolve bottlenecks and dependencies, as well as balance work and strategic priorities. 

Who You Are

• You have at least five (5) years in the Medical Device / Pharma / Biopharmaceutical industry. Experience in Quality, Compliance, Regulatory and/or Validation is a plus but not mandatory. 

• You hold a Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience. 

• You demonstrate experience and knowledge of Daily Management and Continuous Improvement best practices.

• You are knowledgeable of the European, US, China, and International cGMP regulations and demonstrated ability to adequately interpr