Strategic Quality Partner

Roche; Tucson (AZ); On-site; USD 104,000 - 222,000; Full time

Benefits offered by this job

Annual bonus

Benefits package

Job summary

Roche in Tucson, Arizona is seeking a Strategic Quality Partner to drive end-to-end quality leadership in new product development and updates. You will align global requirements across Customer Areas, and partner with Development Leads, Regulatory, Operations and Post-Market Quality to ensure compliant, high-quality solutions.

Ideal candidates have a science/engineering/business background with 8+ years in diagnostics, strong regulatory knowledge, and bold, collaborative leadership to steer

Qualifications

• Bachelor's degree in science, engineering, business or related field; MBA advantageous.
• 8+ years in the diagnostics industry or related business functions.
• Strong scientific/technical background with product knowledge in IVD products.

Responsibilities

• Ensure consistent interpretation & implementation of global requirements across Customer Areas.
• Incorporate lessons learned into project support and feed PostMarket Quality feedback into requirements.
• Ensure development project plans contain deliverables to deliver safe and compliant solutions.
• Support internal and external audits.
• Lead constructive discussions at project team meetings.
• Drive awareness and adoption of risk-based decisions and enable risk-based decision making.

Skills

Cross-functional leadership

Regulatory compliance

Project management

Quality systems

Education

Bachelor's degree in science/engineering/business

MBA or advanced degree advantageous

Job description

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.

The Position

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 an inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing inclusion and belonging enables us to create a great place to work and to innovate for patients.

The Strategic Quality Partner

acts as a single point of contact within project teams (New product development / Product update) for a portfolio of products assigned to them. The SQP leads and drives for decisions for strategic topics from a compliance and product quality perspective. The SQP collaborates with internal and external stakeholders across the value chain to streamline the development process and integrate continuous learnings. Stakeholders include, but are not limited to Development Leads, Project Leaders, Regulatory Affairs, Operations, Global Customer Support, and Post-Market Quality.

The Opportunity

• Ensure consistent interpretation & implementation of global requirements across Customer Areas (CAs)
• Incorporate lessons learned from all areas of quality across Customer Areas (CA) into project support and ensure PostMarket Quality feedback is built into the requirements
• Ensure development project plans contain the right deliverables according to the Design & Development module to deliver safe and compliant solutions
• Support internal and external audits
• Lead and facilitate constructive discussions e.g. at project team meetings
• Drive awareness and adoption of the Risk Enabler inside and outside of Global Quality & Regulatory decision making; prepare and enable risk-based decisions
• Partner to ensure effective resolution of issues (e.g. CAPA, NC)
• Ensure effective feedback loops and information flow for milestone review

Who You Are

• Bachelor\'s degree in science, engineering, business administration or a related field. MBA or advanced degree is considered an advantage
• 8+ years of experience in the diagnostics industry or a related field in business related Functions
• Strong scientific and technical background with sound product knowledge, ideally with assay/reagents/system/hardware/software development experience for IVD Products
• Strong business and financial acumen with an enterprise mindset
• Knowledge of Regulations pertaining to the environment (i.e. ISO 13485, ISO 14971, GDP, GMP, IVDR, others)
• Excellent communication, presentation, and negotiation skills
• Strong agile knowledge and capabilities demonstrating new ways of working
• Pragmatic decision making and ability to move forward without a perfect solution
• Demonstrated thorough E2E understanding for lifecycle management
• Strong leadership capabilities, with experience in leading cross-functional teams (Squad Lead, Matrix Lead) and driving change

Locations

You are located in Tucson, Arizona. This is a primarily onsite role.

Relocation benefits are not available for this position.

The expected salary range for this position based on the primary location of Tucson is $103,800 and $221,780. 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

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.

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.

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.