Senior Manager/Director of Quality

HistoWiz; New York (NY); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player in biomedical research is looking for a Senior Manager/Director of Quality to lead quality assurance efforts. This role involves managing compliance across laboratory operations, developing SOPs, and conducting audits to ensure adherence to GLP regulations. With a focus on quality systems and team development, the position offers a chance to make a significant impact on research integrity. The company provides comprehensive health coverage, parental leave, and a 401k plan, making it an attractive opportunity for those passionate about quality assurance in the scientific field.

Benefits

Comprehensive health coverage

Parental leave

401k

Onsite gym

Qualifications

• 5+ years in Quality Assurance within CRO, pharma, biotech, or diagnostic labs.
• Experience with audits and GLP review.

Responsibilities

• Develop and update SOPs and BOPs.
• Lead internal audits and host client audits.
• Manage deviations, audit observations, and corrective actions.

Skills

Quality Assurance

GLP Compliance

Auditing

SOP Development

Training

Client Interaction

Education

BS/MS in a scientific or technical field

Job description

Join to apply for the Senior Manager/Director of Quality role at HistoWiz.

HistoWiz, based in New York City, is the largest online histopathology company dedicated to accelerating biomedical research and global collaboration. We are seeking a Quality Assurance Specialist to oversee GLP QA audit activities across our domestic and international sites, ensuring compliance with regulations, policies, and procedures.

Role Overview: The Senior Manager/Director of Quality will manage quality and compliance in laboratory operations, support the build-out of quality systems for GLP labs, lead audits, and respond to client inquiries. Experience with CAP/CLIA is a plus.

Key Responsibilities:

1. Develop and update SOPs and BOPs.
2. Provide guidance and training on GLP regulations.
3. Lead internal audits and host client audits.
4. Ensure GLP compliance and prepare QA documentation.
5. Manage deviations, audit observations, and corrective actions.
6. Lead QA team development.

Minimum Requirements:

• BS/MS in a scientific or technical field.
• At least 5 years in Quality Assurance within CRO, pharma, biotech, or diagnostic labs.
• Experience with audits and GLP review.
• Knowledge of GLP/GCP regulations and standards (EPA, OECD, FDA, EU).

Preferred Additional Experience:

• Histology, histotechnology, and IHC experience.
• Lab management experience.

Benefits include: comprehensive health coverage, parental leave, 401k, onsite gym, and more.