Top 37 Director of quality assurance Jobs in Somerset Nj

Site Quality Director (Somerset New Jersey)
Ardena —Somerset, NJ
- $200,000 - $220,000 a year
- Hybrid work
- Bachelor of Science
- 11+ years
- Bachelor's degree
Executive Director of Quality Assurance
SystImmune —Princeton, NJ
- $240,000 - $300,000 a year
- Full-time
- Hybrid work
- Nursing
- Office
- Bachelor's degree
- Paid holidays
- Disability insurance
8h
Director, PV QA DSI
Daiichi Sankyo, Inc. —Basking Ridge, NJ
- $184,240 - $276,360 a year
- Master's degree
- Bachelor's degree
- Mentoring
Director, Data Quality and Process, External Data Clinical Data Management
Genmab —Princeton, NJ
- $189,200 - $283,800 a year
- Online Application
- 5 years
- Bachelor's degree
- Doctor of Philosophy
- Commuter assistance
- Paid parental leave
Director, Quality Assurance
Avet Pharmaceutical —E Brunswick, NJ
- $170,000 - $200,000 a year
- Full-time
- English
- Office
- Supervising experience
- Paid holidays
- Health insurance
Quick Apply
Director, Quality Compliance
Cellares —Bridgewater, NJ
- $90,000 - $250,000 a year
- Full-time
- 5 years
- Mentoring
- Senior level
- Health insurance
- Dental insurance
Quality Assurance Director - GMP ESO Biotechnologies
Recordati —Bridgewater, NJ
- $149,160 - $223,740 a year
- Weekends as needed
- Hybrid work
- 11+ years
- English
- Office
- AD&D insurance
- Paid holidays
Director, Data Management Process, Quality & Inspection Readiness
Regeneron —Warren, NJ
- $183,100 - $305,200 a year
- Office
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
Director, Corporate Quality Management System (QMS)
Integra LifeSciences —Princeton, NJ
- $166,750 - $228,850 a year
- Email
- Engineering
- 11+ years
- Office
- Disability insurance
- Health insurance
Director of Quality
PIM BRANDS LLC —Somerset, NJ
- $120,000 - $130,000 a year
- Microsoft Excel
- 5 years
- Computer literacy
- Health insurance
- Dental insurance
Quick Apply
Director, Quality
Catalent —Princeton, NJ
- $190,000 - $230,000 a year
- Email
- Engineering
- Organizational skills
- In-person
- Paid holidays
- Health insurance
Head of Quality Assurance, Drug Product, GMP QA
Daiichi Sankyo, Inc. —Basking Ridge, NJ
- $226,275 - $377,125 a year
- English
- Bachelor's degree
- Travel
Director of Quality and Clinical Excellence
NJ Palliative Care Solutions —Edison, NJ
- $160,000 - $190,000 a year
- Full-time
- Management
- BLS Certification
- ACLS Certification
Quick Apply
QA Manager/Associate Director – Quality Assurance (Job Code: QA)
Primera Analytical Solutions —Princeton, NJ
- 5 years
- Bachelor of Science
- Bachelor's degree
8d
Senior Director, Supplier & External Manufacturing Quality
Integra LifeSciences —Princeton, NJ
- $192,050 - $263,350 a year
- Email
- Engineering
- 11+ years
- Master's degree
- Disability insurance
- Health insurance
Director of Quality
XP Power —High Bridge, NJ
- $160,000 - $180,000 a year
- Full-time
- 11+ years
- Manufacturing
- Senior level
- Paid holidays
- Disability insurance
Quick Apply
5d
Director, Product Quality Lead
Kardigan —Princeton, NJ
- $194,000 - $250,000 a year
- 11+ years
- Bachelor's degree
- Senior level
3d
Associate Director, Site Quality Compliance Lead
Legend Biotech US —Raritan, NJ
- $168,372 - $220,988 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- 5 years
Quick Apply
Director, Quality Data Analytics
Integra LifeSciences —Princeton, NJ
- $166,750 - $228,850 a year
- Email
- 7 years
- Computer Science
- SQL
- Disability insurance
- Health insurance
Director, GPV Compliance & Business Management (QA)
Otsuka Pharmaceutical Development and Commercialization, Inc. —Princeton, NJ
- $186,489 - $278,875 a year
- Full-time
- 6 years
- Microsoft Outlook
- Bachelor's degree
- AD&D insurance
- Paid holidays

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Site Quality Director (Somerset New Jersey)

Ardena -
Somerset, NJ

Apply Now

Job Details

$200,000 - $220,000 a year

Qualifications

Customer communication
Team leadership
GMP
General management
Cross-functional communication

Full Job Description

About Ardena

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.

The Ardena Group operates from five sites across Europe and the United States, employing more than 750 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.

For the Ardena Business Unit based in Somerset (US), we are looking for a [Job Title]

Ardena provides integrated services spanning drug substance development, drug product formulation, GMP manufacturing, bioanalytical services, clinical logistics, fill and finish, and CMC regulatory support.

Job Overview

Position: Site Quality Director

Department: Quality

Location: Somerset, New Jersey (US)

Role Description

The Site Quality Director is accountable for the end-to-end Quality function at the site, ensuring full compliance with FDA, EU GMP and global regulatory requirements while enabling efficient, business-aligned operations.

This role requires a strategic quality leader who combines deep GMP expertise with strong business acumen, drives continuous improvement, and partners cross-functionally to support sustainable growth, operational excellence, and customer satisfaction.

Key Responsibilities

Quality Leadership & Compliance

Ensure the site operates in full compliance with regulatory and internal standards
Ensure robust oversight of: batch certification, deviations, CAPA, change control, complaints and recalls, validation and qualification
Drive a proactive quality culture focused on Right-First-Time and data integrity
Translate corporate strategy into site-level quality objectives and KPIs
Act as a business partner to General Manager, Operations, and Commercial teams
Balance compliance, cost, cycle time, and customer expectations
Support business growth by enabling: On-time product release, Inspection readiness, regulatory approvals
Contribute to client interactions and proposals, ensuring quality positioning is competitive and credible
Drive measurable improvements in: cycle time (e.g., batch release, deviation closure), Right-First-Time performance, Cost of Poor Quality (COPQ), lead initiatives to simplify processes while maintaining compliance
Build, lead, and develop a high-performing quality organization
Foster a culture of: accountability, ownership, cross-functional collaboration
Ensure appropriate succession planning and capability development
Coach teams on risk-based thinking and pragmatic GMP application
Implement robust quality risk management (ICH Q9) practices
Maintain a constant state of inspection readiness

Qualifications:

Education or Equivalent: BS or BA in Chemistry, Biological Sciences, or other related scientific discipline or equivalent experience.

Experience: 15 + years of Scientific or Quality Assurance and/or Quality Control Experience

Knowledge/Skills Requirements:

Clear understanding of cGMPs.

Open and clear communication with direct reports.
Communicates clearly with internal and external clients, both verbal and written.
Cooperates with co-workers; is a team player. Willingness to contribute to team activities.
Demonstrates flexibility in organizing work and priorities.
Excellent organizational skills relating to management of associates daily activities.
Excellent problem-solving skills and decision-making skills to identify and solve work related issues.

Alignment with Ardena’s CARE values: Communicative, Accountable, Reliable, and Excellent

What Ardena Offers

Ardena is a science-driven and people-focused employer. Working at Ardena means contributing to pharmaceutical projects that support the availability, safety, and quality of medicines for patients worldwide.

Ardena offers an international working environment where employees are encouraged to develop their expertise, take ownership, and grow their careers across functions and locations.

Benefits and perks at Ardena include:

Competitive salary and tailored benefits package (adjusted per role and location)
Flexible working arrangements and paid annual leave (where applicable, depending on role and site)
International and collaborative work environment across European and US sites
Access to professional development and training programs
Meaningful work on pharmaceutical development projects that advance patient health
A values-driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, and Excellent

Salary Range: $200,000 - $220,000

How to Apply

Ready to advance your career in pharmaceutical development? Apply now through the Ardena Careers website at careers.ardena.com.

Apply Now

Refine Your Search

director of quality assurance jobs in somerset nj

Site Quality Director (Somerset New Jersey)

Executive Director of Quality Assurance

Director, PV QA DSI

Director, Data Quality and Process, External Data Clinical Data Management

Director, Quality Assurance

Director, Quality Compliance

Quality Assurance Director - GMP ESO Biotechnologies

Director, Data Management Process, Quality & Inspection Readiness

Director, Corporate Quality Management System (QMS)

Director of Quality

Director, Quality

Head of Quality Assurance, Drug Product, GMP QA

Director of Quality and Clinical Excellence

QA Manager/Associate Director – Quality Assurance (Job Code: QA)

Senior Director, Supplier & External Manufacturing Quality

Director of Quality

Director, Product Quality Lead

Associate Director, Site Quality Compliance Lead

Director, Quality Data Analytics

Director, GPV Compliance & Business Management (QA)

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