Hiring.Camp

Associate Director, Quality Systems and Compliance

Lexeotx

·

1 week ago

Salary
$176k – $189k/yr
Location
New York, New York
Workplace
Hybrid
Type
Full-time
Department
CMC
Seniority
Entry
Education
Bachelor
Source
Lever

Description

Role Summary 

We are seeking an experienced Associate Director, Quality Systems & Compliance to lead strategic oversight and continuous improvement of our Quality Management System (QMS), Document Control for Policies, SOPs, Work Instruction & forms, and GxP as well as some non GxP Training programs. This individual will play a critical role in ensuring our quality infrastructure supports the development and commercialization of innovative gene therapies while maintaining compliance with applicable global regulatory requirements. 

The successful candidate will be a hands-on leader with extensive experience implementing and managing electronic quality systems, developing and maintaining controlled documentation, and administering enterprise-wide training programs within a biotechnology or pharmaceutical environment. 

Skills

FDAComplianceProject Management

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Associate Director, Quality Systems and Compliance at Lexeotx • $176k – $189k/yr | Hiring.Camp