At Alamar, we are passionate about enabling our customers to make scientific discoveries that translate into clinical outcomes and benefit patients. Our team is growing quickly as we develop innovative approaches to measure critical protein biomarkers from liquid samples that can enable the earliest possible detection of disease. We believe the next frontier in biology is enabled by measuring proteins at higher sensitivity in highly multiplexed assays at the push of a button, which is something only Alamar can do. As we build our team, we seek collaborative, driven, intellectually curious people committed to solving complex challenges. Our culture rewards accountability and cross functional teamwork because we believe this enables the kind of breakthrough thinking that will accelerate our mission.

As the Sr. Dir/VP of Quality, you will have the opportunity to establish, maintain and improve quality management systems, policies, procedures, compliance and best practices across the Company. You will be responsible for ensuring that quality management systems and programs align with Alamar’s quality standards, supporting continuous improvement and regulatory compliance across all operations. You will direct the Executive Management Review Program and be responsible to ensure appropriate metrics are identified, compiled, and reviewed.

Responsibilities

Develop and execute the company’s quality vision, aligning with business goals and regulatory requirements.
Ensure adherence to FDA (21 CFR Part 820), ISO 13485, IVDR, and other global regulatory standards.
Oversee the establishment, implementation, maintenance, and continuous improvement of Quality Management Systems (QMS) across the company.
Lead internal and external audits (FDA, ISO, notified bodies), ensuring timely resolution of findings.
Partner with R&D, Manufacturing, Regulatory Affairs, and Clinical teams to embed quality into product lifecycle.
Implement robust risk assessment and mitigation strategies, including CAPA, non-conformance, and complaint handling.
Build and mentor a high-performing quality team, fostering a culture of accountability and continuous improvement.
Define and track key quality indicators (KPIs), presenting insights to executive leadership.

Skills / Knowledge Requirements:

Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
15+ years in quality leadership roles within the IVD or medical device industry.
Deep knowledge of global regulatory frameworks (FDA, ISO, IVDR, etc.).
Proven experience of working effectively in a fast-paced life sciences and tools company with mixed Research Use Only (RUO) and IVD products
Proven ability to work successfully cross-functionally and collaboratively to problem solve, initiate and manage projects, influence internal and external groups and provide leadership from a quality perspective.
Highly developed written, oral and interpersonal skills, critical thinking skills, industry practices, current thinking of regulators & Notified Bodies. Dealing with Corporate Functions, presenting to Executive Staff & experience dealing directly with FDA & Global Regulators.

The base salary range for this full-time position is $275,000 - $325,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.

Senior Director/Vice President, Quality

AI overview