Head of Quality

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Job Summary:

As the Operations Quality Site Head for Suzhou you are fully accountable for the quality of the products manufactured at the site and for ensuring end-to-end compliance with global specifications local Health Authority regulations and corporate quality standards. You serve as a key member of the Global perations

Quality Leadership Team (GOQLT) and the Site Leadership Team modeling Agile behaviors and driving operational excellence.

Main Tasks & Responsibilities:

Drive business results and customer value

a) Responsible for ensuring that manufactured products in Suzhou 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.

b) 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.

c) 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.

d) 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.

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

f) Appointed as the Site Management Representative and Person Responsible for Regulatory Compliance (PRRC) equivalent under China Medical Device GMP regulations and international standards (e.g. ISO 13485:2016). Accountable for ensuring the sites technical documentation quality management systems

and regulatory filings are meticulously drawn up maintained up-to-date and fully aligned with NMPA FDA and European regulations to safeguard our right to operate.

2. Advance the work of the Network making tradeoffs and breaking silos

a) 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.

b) 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.

c) 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

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

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

c) 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.

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

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

f) Be the champion and advocate for Engrained Quality at the Site. Build a culture of continuous improvement and model lean leadership principles.

g) Ensure your organization proactively seeks out and considers the voice of the customer in defining their priorities and outputs.

Enable the organizations New Ways of Working

a) Act as role model for Agile Leadership behaviors as well as for our culture mindset & behaviors as defined in

b) Model behaviors to support the organizations transformation to new more Agile Ways of Working - e.g. new decision making/governance practices collaboration etc.

c) 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.

Qualification & Experience

• Bachelors / Master degree in Life; Science Pharmacy or related subject.
• At least ten (10) years in the Medical Device/Pharma/Biopharmaceutical industry with 5 years working in Quality Compliance Regulatory and/or Validation.
• Excellent knowledge of the European US China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality
• standards. Demonstrated experience in Health Authority inspections.
• Demonstrated experience leading multi-jurisdictional audits and regulatory mappings for global facility convergence.

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.