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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

Operations Quality Site Head - Suzhou

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 Operations Quality Site Head in Suzhou, you are accountable for the quality of the products manufactured at the site(s) you represent and ensuring compliance with valid specifications and regulatory requirements. The Operations Quality Site Head is a member of the Global Operations Quality Leadership Team (GOQLT), a member of the Site Leadership Team and the Operations team (s) that you support.

You are a strong and visionary leader who is ready to partner with our operations and manufacturing sites to deliver high quality products to customers and patients, ensures our right to operate and helps us create value through leveraging analytics, process excellence, Lean Manufacturing and continual improvement efforts.

You will be responsible to …

Drive business results and customer value

Responsible for ensuring that manufactured products in Suzhou and potentially other Chinese sites meet Health Authority regulations, Notified Body requirements, Company standards and expectations. Establish and support inspection readiness to ensure successful outcomes. Prepare adequate and timely responses to any inspection observations and implement appropriate and thorough corrections, as necessary.

Engage and influence the organization to ensure that Product Quality is our focus by ensuring that products manufactured in Suzhou meet regulatory requirements and product specifications. Works directly in a complex, global environment with the chapters and the other Network Leads to deliver high quality products, ensure our right to operate and continuously improve. 

Provide leadership and guidance to staff directing Quality functions, manage performance and development of direct reports to ensure achievement of organizational, and departmental goals and a productive environment.

Maintain an effective Quality governance and continually improve the governance to meet business and compliance needs. Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.

Develop annual budget, revise forecasts to meet business needs and monitor/control expenditures to assure efficient use of company resources.

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

Partner with the Operations Site Head on strategic business direction and decisions. Break down silos and improve working effectiveness as an ‘integrator’ across the organization as needed; in particular through collaboration with other Networks Leaders and stakeholders to resolve escalated bottlenecks and dependencies, as well as rebalance work & help in line with greater strategic priorities 

Build and maintain strong partnerships with other site and network leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.

Coordinate with Functional Partners to aggregate upcoming LCTs’ needs and upcoming priorities, to better understand upcoming resource demands on the Network

Empower and enable the Network

Develop and communicate organizational strategies, which ensure the GMP compliance of the site, continuous improvements and achievement of long term goals. 

Negotiate with Senior Leadership across the organization to influence decision making.

Lead, coach, and guide the organization. Manage performance and development of the members of the Quality Unit to achieve organizational goals and employee personal and professional growth in accordance to Servant-Leadership principles.

Build a strong pipeline of talent and robust succession plans for key positions.

Manage and administer people processes including selection, hiring, promotion, and compensation and provide training of personnel on company and department policies systems and processes.

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

Build a culture of continuous improvement and model lean leadership principles.

Ensure your organization proactively seeks out and consider 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 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 – e.g. new decision making/governance practices, collaboration, etc.

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: 

  • High degree of subject matter expertise:
  • At least eight (8) years of demonstrated people leadership experience or equivalent experience.
  • Experience in directing and leading large successful organizations.
  • Demonstrated experience and knowledge of Quality operations and processes.
  • 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.
  • Demonstrated experience in European, US and other relevant Health Authority inspections.

Locations:

You are based in Suzhou.

At the Company's discretion, an exception to the location requirement could be made under extraordinary circumstances. 

As this position is part of a global organization, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.

Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients

Roche is an equal opportunity employer

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.

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Confirmed 15 hours ago. Posted 8 days ago.

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