QA Manager

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Global Regulatory Compliance and Systems - Quality Management System Excellence SubChapter Lead Planning & Measurement

Job title for posting: 

Global Quality, Regulatory and External Affaires_Global Regulatory Compliance and Systems_QMSE Planning & Measurement Subchapter Lead

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 Subchapter Lead for QMSE Planning & Measurement, you will be the leading figure and keypoint of contact for the Quality System capabilities.  You will improve the subchapter’s overarching expertise based on current and upcoming needs to deliver on the QMSE strategy priorities.

You will be responsible to excel in developing the capabilities of subchapter members, including their skills in quality planning, risk management, influencing, strategic thinking, verbal and written communication.  As a people leader of subchapter members, you will be responsible for designing and optimizing subchapter members’ personal professional journey and coaching your direct reports.  Furthermore, you will have the responsibility to maintain and improve all processes, data, and technology associated with the subchapter.  You will work closely with your peer subchapters in Planning & Measurement.

In your work with Chapter members, you’ll apply Vision, Architecture, Coach and Catalyst (VACC) principles to encourage:

• Individual contributors to proactively seek advice to develop the most creative and innovative Quality Planning, Audit strategy, Management Review strategies
• Advocating inclusion of innovative approaches within projects that help advance our objectives
• Ongoing knowledge sharing of QS, Regulatory and Project Intelligence
• Self directed career development
• Radically simplifying and focusing on the most impactful work to advance the customer needs
• Standardizing processes, leveraging systems and tools and valuing data as an asset.

Your ensure compliance with applicable and regional regulatory requirements, ensuring our Quality Management System is protected.  You will work closely with the QMSE Leadership, Operations Quality Site Heads, Functional Leaders, other Quality & Regulatory teams to ensure subchapter has necessary capabilities, set priorities, to ensure achievement of organizational, quality, and departmental goals as well as how best to allocate resources to Squads and Community of Practices.  

As part of your responsibility to ensuring compliance, you are accountable to plan our certified quality systems and to maintain the QMS certifications (e.g. ISO 13485, GMP, etc.), the site’s audit readiness and audit support, deliver management review and the respective monitoring & measuring activities necessary to maintain our right to operate and deliver high quality products around the world.  Your role as a mQMS steward is vital to our global success. By taking ownership of how our processes are understood, connected, and documented, you drive operational excellence for teams around the world.  The QMS Planning & Measurement Subchapter Lead is a member of the Global Regulatory Compliance and Systems Extended Leadership Team (GRC&S exLT). 

You are a strong and visionary 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 leveraging analytics, process excellence, and continual improvement efforts.

You will be responsible to …

• Drive business results and customer value through development and coaching of subchapter members
  • Knowledge and expertise management
  • Growth of technical capabilities, coach, and empower staff to deliver best in class results
  • Subject matter expert with US FDA, IVDR, NMPA (both medical device & pharmaceutical), ISO, Notified Bodies, & other regulatory bodies to advance mQMS objectives in documented information.
  • Responsible for effective resource management across the team and across the other Documents Operations Partnering subchapters.
  • Accountable to ensure that our QMS meets 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 related to the QMS and ensure corrections are adequately implemented within the QMS. 
  • Maintain an effective Quality Management System Plan and continually improve 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.
  • Will contribute to the development of the 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 Quality Site Head(s), Global Regulatory Compliance & Systems Chapter LT and other Quality and Regulatory leaders 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 Network and Chapters 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 chapter leaders to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.
  • Coordinate with Quality Site Heads to aggregate upcoming QSE Planning & Measurement needs and upcoming priorities, to better understand upcoming resource demands on the Chapters and Networks

• 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.
  • 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 considers the voice of the customer in defining their priorities and outputs.

• Enable the organization’s New Ways of Working
  • Model behaviors to support the organization’s transformation to new, more Agile Ways of Working – e.g. new decision making/governance practices, and collaboration.
  • Everything you do should contribute directly to the achievement of our Roche Ten Year ambitions.

What else do you have in your toolbox: 

• High degree of subject matter expertise:
  • At least three (3) years of demonstrated people leadership experience or equivalent experience.
  • Experience in directing and leading successful organizations.
  • Demonstrated experience and knowledge of QMS and processes.
  • At least five (5) 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. An 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:

Suzhou, China

As this position is part of a global organization, international business travel may be required depending upon 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

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.