Senior Director/Vice President, Quality at Alamar Biosciences

Fremont, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Medical DevicesIndustries

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 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, and experience dealing directly with FDA & Global Regulators

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

Quality Management Systems

FDA 21 CFR Part 820

ISO 13485

IVDR

Regulatory Compliance

Internal Audits

External Audits

Risk Assessment

QMS Implementation

Executive Management Review

Alamar Biosciences

Develops technology for protein detection and measurement

About Alamar Biosciences

Alamar Biosciences focuses on the study of proteins, known as proteomics, to enhance disease detection and treatment. The company has created NULISA™, a technology that can detect and measure proteins in the human body with high sensitivity and a wide range. This allows researchers and clinicians to profile clinically relevant protein biomarkers, which are essential for developing new diagnostic tests and treatments for various diseases. Alamar's ARGO™ system complements NULISA™ by providing a fully automated, high-throughput platform for precision proteomics. Unlike competitors, Alamar's technology simplifies the process, reducing the need for extensive technical expertise, making it more accessible to clients. The goal of Alamar Biosciences is to improve our understanding of proteins in health and disease, ultimately leading to better early detection and treatment options.

Hayward, CaliforniaHeadquarters

2018Year Founded

$225.7MTotal Funding

GRANTCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

401(k) Company Match

401(k) Retirement Plan

Performance Bonus

Company Equity

Risks

Increased competition from Olink and SomaLogic may impact Alamar's market share.

Scaling production in Europe and APAC could strain resources and affect quality.

Regulatory hurdles in new regions may delay product launches and affect revenue.

Differentiation

Alamar's NULISA™ technology offers unprecedented sensitivity in protein detection.

The ARGO™ system automates high-throughput proteomics, reducing the need for technical expertise.

Alamar's focus on early disease detection sets it apart in the biotechnology field.

Upsides

ISO 13485:2016 certification boosts Alamar's credibility in the medical device industry.

European expansion with Milan headquarters enhances market reach and client service.

$10M investment accelerates Alzheimer's diagnostics development, strengthening Alamar's market position.

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