Executive Director, Quality Assurance
ConfidentialNew York, NY, United States- Full-time
Executive Director, Quality Assurance
About the Company
Innovative biotech company developing selective monoclonal antibodies for rare autoimmune diseases
Industry
Pharmaceuticals
Type
Public Company
Employees
11-50
Categories
- Pharmaceuticals
- Health Care
- Academic Research
- Biotechnology
- Medical Care
- Medical Conditions
- Medicines
- Manufacturing
- Medicine
- Chemical Products
About the Role
The Company is seeking an Executive Director for Quality Assurance to lead the development and execution of a comprehensive QA strategy. The successful candidate will be responsible for building and leading a QA team to ensure global GMP and GLP compliance in the development, manufacturing, and regulatory approval of the company's products. This role is pivotal in maintaining the company's inspection readiness and requires a deep understanding of QA processes, particularly in the context of combination product drug delivery systems. The Executive Director will work closely with cross-functional teams to meet global regulatory requirements and will be integral in supporting the company's quality culture and continuous improvement initiatives.
Candidates for this role at the company should have a BS or MS degree in a relevant field and a proven track record of progressive QA leadership in the biotech or pharma industry, with specific experience in combination product development. Deep knowledge of GMP regulations, device-specific standards, and quality systems is essential. The role demands a leader with strong collaboration, influencing, and project management skills, who can effectively represent QA in governance forums and during health authority inspections. Experience in risk management, design quality activities, and pre-commercial biotech environments is also required. The ideal candidate will be a results-oriented individual with a forward-thinking mindset, capable of managing multiple projects and driving a culture of quality, accountability, and collaboration.
Hiring Manager Title
VP, Head of Quality
Travel Percent
20%
Functions
Create a job alert for this search
Director Quality Assurance • New York, NY, United States
- Promoted
EXECUTIVE DIRECTOR. QUALITY ASSURANCE
City of New YorkNew York, NY, United States- Promoted
Director of Quality Assurance and Training
Fedcap Rehabilitation ServicesNew York, NY, United States- Promoted
Director of Quality Assurance and Training
The Fedcap GroupNew York, NY, United States- Promoted
Senior Director of Quality Assurance
ConfidentialNew York, NY, United States- Promoted
Director Quality Assurance Quality Control
ClinLab StaffingEssex Fells, NJ, United States- Promoted
Executive Director, Digital Regulatory and Safety
MerckRahway, NJ, US- Promoted
Director of Engineering and QA (Consumer Appliances)
SteelStoneBrooklyn, NY, United States- Promoted
QA Director
VeracityBerkeley Heights, NJ, United States- Promoted
Associate Director, Quality Management
Jacobi Medical CenterBronx, NY, US- Promoted
Director Global Quality Supplier Quality Management
MerckRahway, NJ, US- Promoted
Quality Assurance Manager
The Judge GroupLinden, NJ, United States- Promoted
Director - Assurance National Office (Software Audit Tools)
EisnerAmperNew York, NY, United States- Promoted
Director of GCP / QA
Advanced Recruiting PartnersNew York, NY, United States- Promoted
Associate Director, Quality Risk Specialist
New Jersey StaffingMadison, NJ, US- Promoted
Director, Clinical Quality Assurance
EisaiNutley, NJ, United States- Promoted
Quality Assurance Director - Electronics - Edison, NJ
Michael PageEdison, NJ, United States- Promoted
Senior Director, Clinical Quality Assurance
RealNutley, NJ, United States- Promoted
