Quality Operations Director - Lead Compliance & Excellence

BioTissue, Inc.; Miami, Northern (FL, KY); Hybrid; USD 156,000 - 195,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401(k) Retirement Savings Plan

Paid Time Off

Job summary

BioTissue, Inc. is seeking a Director of Quality Operations to lead the site quality-operations across manufacturing, packaging, labeling, and distribution.

You will ensure GMP/GTP/ISO compliance, oversee quality engineering, and maintain the Quality Management System, driving continuous improvement while managing budgets and cross-functional collaboration with Operations, R&D, and Supply Chain. The role requires strategic leadership, deep regulatory knowledge, and a track record of delivering

Qualifications

• Bachelor's degree in Life Sciences required.
• Master's degree in Life Sciences, QA/Regulatory Affairs, MBA, preferred.
• AATB CTBS certification preferred.
• ASQ CQE certificate preferred.
• CQA certificate preferred.

Responsibilities

• Lead the site quality-operations across manufacturing, packaging, labeling, distribution, and quality engineering.
• Ensure compliant product disposition and release under GMP, GTP, ISO requirements.
• Drive quality improvements via Change Control, CAPA, risk management, and audits.
• Maintain and improve the site Quality Management System and regulatory readiness.
• Manage department budgets, resources, and team workload.

Skills

Leadership

Regulatory compliance

Quality systems

People management

Cross-functional collaboration

Strategic thinking

Education

Bachelor's Degree in Life Sciences

Master's Degree in Life Sciences

AATB CTBS

ASQ CQE

CQA

Tools

eQMS

ERP systems

Job description

BioTissue, Inc. is seeking a Director of Quality Operations to lead the site quality-operations across manufacturing, packaging, labeling, and distribution.

You will ensure GMP/GTP/ISO compliance, oversee quality engineering, and maintain the Quality Management System, driving continuous improvement while managing budgets and cross-functional collaboration with Operations, R&D, and Supply Chain. The role requires strategic leadership, deep regulatory knowledge, and a track record of delivering