Head of Quality Operations & Regulatory Compliance

BioTissue Holdings Inc

Miami (FL)

On-site

USD 156,000 - 195,000

Full time

26 hours ago

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Benefits offered by this job

Medical, Dental, and Vision Insurance

401(k) Retirement Savings Plan

Paid Time Off

Job summary

BioTissue Holdings Inc. in Miami, FL, seeks a Director of Quality Operations to lead the site quality-operations across manufacturing, packaging, and distribution. You will ensure GMP/GTP/ISO compliance and drive continuous improvement in the Quality Management System.

The role requires strategic leadership, budget management, and cross-functional collaboration with Operations, R&D and Supply Chain to ensure product quality and patient safety. Strong regulatory acumen is essential for success.

Qualifications

Bachelor's Degree in Life Sciences or related field required.
Master's Degree in Life Sciences, QA/Regulatory Affairs, MBA or related field preferred.
AATB CTBS, CQE, CQA certifications preferred.
Minimum 15 years of experience in FDA-regulated industry required.
Minimum 5 years QA and people management experience required.

Responsibilities

Lead and direct site quality-operations across manufacturing, packaging, labeling and distribution.
Ensure compliant product disposition and release under GMP, GTP, ISO and other regs.
Drive QMS improvements via Change Control, CAPA, Risk Management and Audit programs.
Collaborate with Operations to align quality strategies with manufacturing goals.
Monitor quality performance metrics and report to site leadership and QMR.
Manage budget, resources and personnel development within the Quality dept.