Sr Quality Risk Management Specialist
Genentech - Switzerland, FL

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Our Global Quality Risk Management department (PTQS) is accountable for ensuring that Roche has a current Good Manufacturing Practice (cGMP) compliant and cost efficient Quality System fully integrated into global and site business processes and continuously improved through Quality subject matter expertise.

Your responsibilities are:
The design, deployment, realization and governance of a harmonized Good Manufacturing Practice (GMP) compliant Quality Risk Management (QRM) Program for Pharmaceutical sites, in accordance with current regulatory expectations and Roche’s QRM standards

Establishing processes that ensure proactive identification and management of quality and compliance risks to ensure that we maintain our “right to operate” and provide “quality supply of products” to our patient

Communicating regularly with appropriate management, decision makers and stakeholders to ensure potential quality or regulatory risks that may affect product quality, patient safety or regulatory compliance are escalated and managed adequately

Providing leadership, QRM expertise and facilitation of strategies for complex or cross-site/ cross-product risk management efforts

Deploying the QRM Training Program for all roles involved in QRM activities across all levels of the Pharmaceutical Technical Operations organization (including QRM experts and facilitators)

Developing and training personnel and internal customers on QRM business processes

Implementation of the QRM IT tool for selected sites including training of users on the tool

Qualifications

In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in

bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.

Requirements:
Bachelor's degree (preferably in Science or Engineering) and at least 6-8 years experience in the pharmaceutical, biopharmaceutical, medical device, or related industry, or an equivalent combination of education and experience

Demonstrated expert level risk management skills, including facilitation using risk management tools

Sound experience and knowledge of current Good Manufacturing Practice (cGMP) and/or Quality System regulations

Experience with application of proven process improvement tools and methodologies; LEAN/Six Sigma in areas of Supply Chain Management/Manufacturing/Engineering or Process Development highly preferred

Strong collaborative leadership skills with outstanding communication skills, excellent planning and prioritization ability and demonstrated tolerance for ambiguity

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Who we are

At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases.

Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Genentech - 23 months ago - save job - copy to clipboard
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