Quality Assurance Lead

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

Quality Assurance Lead - Indianapolis, IN

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

We are seeking a highly motivated Quality Assurance Lead who will be responsible for leading and executing on core US affiliate Quality accountabilities within the Medical Quality & Safety remit. This person will drive the timely execution of key outputs and activities, working in support of our strategic outcomes, and is dedicated to our organizational commitment of continuous improvement, patient safety and customer centricity. 

The Opportunity:

• Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures.

• Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.

• Provide expert Quality support to US/RDC Commercial Operations and assist the organization with testing and monitoring of conformance to established quality assurance processes and standards.

• Develop and implement/eliminate quality strategies, policies and processes as needed, enlisting cross-functional support to ensure RDC compliance

• Accountable for internal and external communications that adhere to corporate identity standards and regulatory/legal guidelines. 

• Collaborate and establish productive cross-functional partnerships within the US and globally as business needs arise

• Lead or contribute to the resolution of complex quality and regulatory problems, identifying and mitigating risks

• Manage or support quality and regulatory audits, monitoring and/or inspections, including preparing adequate and timely responses to any inspection observations and implementing appropriate corrections, as necessary

Who You Are:

Minimum Requirements:

• Bachelor’s degree and 8+ years of quality or training/learning experience OR 12+ years of related experience

Preferred Qualifications:

• You possess excellent problem-solving, customer service, negotiation, interpersonal, decision-making, leadership, and communication skills. These skills will enable you to effectively collaborate with stakeholders and lead with confidence.

• You have a comprehensive understanding of Quality Management System regulations and policies, enabling you to navigate compliance requirements effectively. 

• Your strong analytical skills and problem-solving ability will allow you to gather data, analyze information, create monitoring tools and manage diverse information across several corporate databases, repositories and enterprise applications.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of Indianapolis, IN is $103,900 - $192,900.  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.