Global Head of Operations Quality

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

Who We Are

At Roche, we are passionate about transforming patients' lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single 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.

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.

The Opportunity

We are seeking 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, ensure our right to operate, and help create value through process excellence and continual improvement efforts.

As the Head of Quality, you enable and empower your team to deliver our vision through strategic development and deployment, embedding new ways of working, and demonstrating VACC (Visionary, Architect, Coach, Catalyst) leadership behaviours. You will be a member of the Global Quality and Regulatory leadership team and be a key representative of the global function to the Roche Global Operations function and the Global Operations Leadership Team (GOLT). You will build a high performing team in the areas of QMS strategy, governance, and analytics, deviation management, document and change control, quality assurance, supply chain, and supplier quality.

You will partner primarily with the Roche Diagnostics Global Operations organization, including the Heads of the manufacturing units, Supply Chain, and Procurement to support them in the delivery of their respective strategies and solutions. You will identify the design and development of strategies securing our right to operate and to enable global access to our diagnostics solutions. You will play a key role in implementing relevant aspects of the Diagnostics Strategy and contribute to the overall Roche Diagnostics Vision.

Job Facts

• Provides leadership and strategic direction for quality operations with teams located across the Globe (currently in Europe, UK, US, China and South Africa).

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

• Responsible for ensuring that manufactured product in Diagnostics 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 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 meet regulatory requirements and product specifications. Works directly in a complex, global environment to deliver high quality products, ensure our right to operate and continuously improve.

• Maintain an effective Quality Management System governance, continually improve the governance to meet business and compliance needs and ensure that the QMS meets the long-term operational strategy for the Diagnostics Division. Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management.

• Partners with Global Operations to ensure the manufacturing and global distribution of our quality diagnostics solutions and to maintain and continually improve our Right to Operate at all sites.

• Responsible for planning, directing and coordinating the management of the quality functions and provides quality oversight to all Global Operations functions.

• Responsible for quality oversight of the global supply chain including suppliers.

• Builds effective relationships with Global Operations and the business with special focus on proactive communication, enabling strategic quality related solutions.

• Demonstrated experience of working in a matrixed organization, ability to build strong relationships and effective stakeholder management.

• Responsible for effective resource management across the teams and sites.

• Drive process standardization and reuse where it makes sense (common assets, technical standards) balancing creativity and innovation.

• Foster an agile mindset and ways of working Build and provide effective leadership for the Quality function in a manner that is consistent with the Roche Values, leadership commitments and Diagnostics Cultural Dimensions.

• Seek to inspire and lead the team to deliver ground-breaking solutions that will ensure that Diagnostics Solutions products are recognized as being the best in the Diagnostics industry and maintains our #1 position in the future.

• Modular QMS governance and modules and strategic deployment including continuous improvement

• Quality planning including certification and legal manufacturer strategiesQuality resource allocation and performance management

• Growth of technical capabilities in the Quality team

• Knowledge & Expertise Management within the Quality team

Who You Are

We are looking for a passionate and decisive business leader. You demonstrate energy, passion, courage, vision and the drive to be at the forefront of innovative technological changes in a competitive environment, for the benefit of patients, our people, and the business. Moreover, you bring:

• 10+ years of progressive Quality experience, preferably both International and US

• Experience in IVDs or Pharma

• Experience leading an Operations/Manufacturing organisation is highly preferred

• Previous demonstrated success in the quality arena

• 5-7 years leading teams and developing/managing a budget

• University degree level qualification in a relevant field (a relevant post-graduate qualification e.g. MSc; MBA; or higher degree is preferred)

• Demonstrated experience with direct interactions with regulatory authorities, including notified bodies, US FDA, and China NMPA.

• Experience successfully leading an organization through FDA and other regulatory inspections

• Strong leadership experience, preferably with extensive experience of building and leading diverse, global teams, and/or matrix leadership of enterprise-level technology-based projects in relevant areas.

• Good balance between technical expertise and organisational leadership, visionary and collaboration.

• Demonstrated passion for and role-modeling of VACC (visionary, architect, coach and catalyst) leadership, with proven ability to lead with a creative mindset, very high self-awareness and for acting as a coach and mentor for other leaders

• Passion for people development and effective mentoring while promoting a culture of trust and support.

• Previous experience in managing areas relevant to Diagnostics Solutions, or business similar experience, coupled with a proven track record of delivery.

• Highly developed leadership and people influencing skills in a matrixed environment, seeking to understand different perspectives and needs, gain broad partner buy-in, and co-create.

• Proven experience in leading collaborative technological innovation and continuous improvement efforts that have yielded tangible results and/or positive impact for patients or business stakeholders.

• Ability to build and sustain strong collaborative relationships and networks with partners across a complex global organisation such as Roche Diagnostics. Able to foster positive partnerships through effective influencing, negotiation, and conflict management skills. Ability to integrate your work in the context of wider strategic frameworks (e.g. other business unit strategies; enterprise-wide strategies, etc) and in a fast-moving and agile environment.

• A strong and influential communicator, able to establish external partnerships with relevant partner organisations and stakeholders in the wider arena, and/or to act as an ambassador for Roche.

• Ability to work independently and influence without authority. Highly developed competencies in thinking strategically, analytically, and innovatively. A critical thinker who is able to analyse possibilities and solutions and make pragmatic trade-offs.

• Act as role-model for Agile Leadership behaviors, as well as for our culture, mindset & behaviors as defined in Roche Operating Principles

• 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

Successful candidates for this role will possess an unyielding mindset to advance and grow the business and will always strive to find meaningful ways to become better versions of themselves - both in thinking and in doing. This translates to:

• Demonstrated enterprise mindset and systems thinking, proven ability to work effectively across multiple leadership areas, global teams and networks, and in a fast paced, volatile, uncertain, complex, and ambiguous (VUCA) environment

• Demonstrated passion for and role modeling progressive leadership with proven ability to lead with a creative mindset, very high self awareness, and for acting as a coach and mentor for other leaders and professionals

• Demonstrated ability to influence with courageous authenticity and build trust with individuals at all levels within the organization

• Demonstrated ability and experience in effectively diagnosing business needs, and shaping and leading large scale global initiatives to address them

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

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a unique opportunity to shape the future of Diagnostics.

Location:

This position can be based at any of our major Diagnostics Manufacturing sites, including Branchburg, Indianapolis, Rotkreuz, Mannheim, or Penzberg. Relocation assistance is available.

Salary:

The expected salary range for this position based on the primary location of Branchburg, NJ is $304,800 - $400,050. 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 benefits.

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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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