Operations Quality Management System Strategy Enabling Lead/Mature Markets

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Who We Are

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.

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.  

Role Purpose

 As the Quality Management System Strategy Enabling Lead with a focus on Affiliate Mature Markets, you are accountable for the global strategy for the Quality Management System  enabling the Mature Market Affiliates.  This includes development and oversight of the framework, governance and certification strategy and ensuring that the QMS is compliant with applicable and regional regulatory requirements for these affiliates and is enabling these markets to succeed with a “right-sized” QMS.  This role also includes responsibility to partner with the other Strategy Enabling Leads and the Regional Heads ensuring that the strategy is understood across the division and is able to be implemented in a simplified manner.   

You are a strong and visionary matrix leader who is ready to enthusiastically partner with our manufacturing sites and Affiliate sites to ensure that our QMS meets requirements and our right to operate and helps us create value through the creation of a best in class QMS.  

You will be responsible to:

• Drive business results and customer value

• Accountable to ensure that our QMS meets Health Authority regulations, Notified Body requirements, Company standards and expectations. Ensure that the responses to any inspection observations related to the QMS are adequately implemented within the QMS strategy. 

• Provide matrix leadership and guidance to staff executing Quality Management System functions including the overall governance of the QMS.

• Maintain an effective Quality Management System governance strategy and continually improve the governance to meet business and compliance needs. 

Advance the work of the Network, making tradeoffs and breaking silos:

• Partner with the Global Regions,  Operations Quality Network Leads and Chapter Leads on developing strategic business direction and decisions related to the QMS and certifications. Break down silos and improve working effectiveness as an ‘enabler’ by influencing the broader Diagnostics organization to embrace the simplified QMS landscape. 

• Build and maintain strong partnerships with the chapter, network leads, the QMS execution team and the affiliates to assure alignment around the QMS strategy, continuous improvement and to assure mutually successful working relationships.

• Coordinate with Quality Site Heads to aggregate upcoming QMS needs and upcoming priorities, to better understand how the most value can be delivered from the QMS. 

Empower and enable the Network:

• Develop and communicate QMS strategies, which ensures compliance with the regulations, continuous improvements and achievement of long term goals.

• Lead, coach, and guide the organization. 

• Be the champion and advocate for Engrained Quality at the Site.

• Build a culture of continuous improvement and model matrix leadership principles.

• Ensure the strategy for the QMS enables the proactive seeking of feedback and consideration of the voice of the customer in defining their priorities and outputs.

Enable the organization’s New Ways of Working:

• Act as role-model for Agile Matrix Leadership behaviors, as well as for our culture, mindset & behaviors as defined in We@RocheDiagnostics

• Model behaviors to support the organization’s transformation to new, more Agile Ways of Working.

• Everything you do should contribute directly to the achievement of our Roche Ten Year ambitions, including:

• Double patient access to novel, high-medical-value diagnostics solutions

• Build the leading, profitable insights business

• Improve patients’ lives via ‘OneRoche Approach’ to ecosystem in every country

What else do you have in your toolbox: 

• At least eight (8) years of QMS experience or equivalent experience and demonstrated experience and knowledge of QMS and processes.  Strategy experience is considered an advantage. 

• At least ten (10) years in the Medical Device/Pharma/Biopharmaceutical industry with 5 years working in Quality, Compliance, Regulatory and/or Validation, preferred or equivalent experience. 

• Bachelor’s / Master degree in Life Science, Pharmacy or related subject. Advanced degree is considered an advantage.

• Excellent knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards.

Locations:

You are local to Indianapolis, Tucson, Rotkreuz, Mannheim, Penzberg or Suzhou.

*Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Tucson is $105,500 and $227,500.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

Who we are

At Roche, more than 100,000 people across 100 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.

As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. These products and services are used by researchers, physicians, patients, hospitals and laboratories worldwide to help improve people's lives.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.