Clinical Quality & Compliance Program Manager

Our Values

Our operational philosophy is guided by a distinct set of principles that dictate how we engage with our community, our customers, and one another.

We prioritize Care for Tomorrow. This value drives us to create a lasting, positive difference in the lives of others. We serve every individual with compassion and understanding, recognizing what truly matters and centering every action around the current and future needs of our community.

We are committed to Delight our Customers. We appreciate every interaction and actively seek ways to bring joy through our service. We practice seeing through the customer's eyes to understand and anticipate their needs, ensuring we consistently deliver solutions that exceed expectations.

We embrace Be Bold

Say It. We believe in direct and open communication, speaking with honesty and courage while respecting others who do the same. We encourage saying what you think, embracing passionate debate, and always bringing the issue to the table. We communicate with unwavering confidence.

We strive to Bring Your Best Self. We ask you to show up and be authentic, utilizing your greatest strengths while staying true to who you are. We encourage you to bring positive energy, be genuine in your approach, and continually seek personal and professional growth. We are uncompromisingly you.

We are dedicated to Innovate Relentlessly. We explore new possibilities and are willing to take calculated risks to advance our mission. We actively challenge the status quo, try new ideas, learn from mistakes, and rally the team to raise the bar. These values are the pillars of our identity and guide our journey.

About the Role

This position is responsible for the end-to-end governance of diagnostic testing products, ensuring they are released with the highest levels of integrity. You will serve as the primary architect of structure, guiding testing solutions from the initial requirements phase through controlled delivery. Your expertise will provide the necessary framework and direction for cross-functional teams relying on your structured thinking to navigate complex diagnostic projects. You will be the steward of quality, protecting data integrity while simultaneously advancing product usability and ensuring alignment with regulatory standards. This role is pivotal in bridging the gap between scientific innovation and compliant, market-ready solutions.

Key Responsibilities

You will establish and manage the critical processes that ensure product excellence and regulatory adherence. Your daily duties will include designing intake procedures that clarify project scope and quality standards with precision. You will establish build checkpoints that align protocols with evolving regulatory expectations and internal guidelines. A significant part of your role will involve conducting systematic reviews of all documentation to confirm accuracy prior to distribution.

You will coordinate shipping activities, ensuring traceability and the timely release of products to the market. In collaboration with partners, you will maintain comprehensive documentation that supports collaborative efforts and prepares the organization for external audits. You will implement verification steps that monitor process performance and highlight specific areas for improvement. also, you will create testing artifacts that effectively translate abstract requirements into actionable validation steps. Finally, you will oversee change management procedures to control updates across instruments and workflows, ensuring consistency and compliance at every stage.

Requirements

To succeed in this role, you must possess a specific combination of experience and technical understanding. You are required to hold three years of progressive experience in a clinical quality role within the life sciences sector. Additionally, you must bring five years of demonstrable experience in compliance-focused environments, showcasing a deep understanding of regulatory landscapes.

You must have a thorough understanding of quality management systems and the regulatory pathways specific to diagnostic products. A core component of this position is the ability to interpret detailed requirements and transform them into practical, verifiable evidence. You must communicate effectively and inclusively with both technical and non-technical stakeholders, ensuring alignment and clarity across all levels of the organization.

Practical Notes

Please This ensures that your application is based on the most current information available.