Associate Director, Vascular QA & Regulatory Readiness

Alcott Global; United States; On-site; USD 140,000 - 180,000; Full time

Job summary

Alcott Global seeks an Associate Director, Quality Assurance – Vascular to provide strategic direction and oversight for QA across vascular manufacturing operations. You will ensure compliance with FDA, EU GMP, ISO 13485, and global standards while collaborating with cross-functional teams to strengthen quality culture.

The role requires a track record in QA, regulatory inspections, risk management, CAPA, deviations, change control, and product disposition, with leadership experience in

Qualifications

• Extensive experience in pharmaceutical and/or medical device manufacturing quality.
• Leadership in quality management, regulatory readiness, risk-based decision making.
• Experience with FDA inspections, 483s, Warning Letters, and regulatory remediation.

Responsibilities

• Lead QA oversight across vascular manufacturing operations ensuring cGMP compliance.
• Act as site SME for manufacturing quality, in-process controls, batch review, product disposition.
• Oversee quality systems including deviations, CAPAs, change controls, investigations and VoE.
• Ensure regulatory readiness and lead FDA inspections, audits, and regulatory responses.
• Drive quality risk management and continuous improvement with cross-functional partners.
• Develop and mentor a high-performing QA organization and promote quality culture.
• Collaborate with Manufacturing, Regulatory, EHS, R&D, and Supply Chain to support operations.

Skills

Quality Assurance

Manufacturing Quality

cGMP Compliance

Regulatory Inspections

Risk Management

CAPA

Deviations

Change Control

Root Cause Investigations

Product Disposition

Quality Systems

Tools

SAP

Enterprise Quality Management Systems

Job description

Alcott Global seeks an Associate Director, Quality Assurance – Vascular to provide strategic direction and oversight for QA across vascular manufacturing operations. You will ensure compliance with FDA, EU GMP, ISO 13485, and global standards while collaborating with cross-functional teams to strengthen quality culture.

The role requires a track record in QA, regulatory inspections, risk management, CAPA, deviations, change control, and product disposition, with leadership experience in