Site Quality Director (Somerset New Jersey)

Ardena Careers; New Jersey; On-site; USD 155,000 - 185,000; Full time

Benefits offered by this job

Competitive salary and tailored benefits

Flexible working arrangements

Professional development access

International work environment

Job summary

Ardena Careers is seeking a Site Quality Director based in Somerset, New Jersey. This strategic role is accountable for the end-to-end quality function at the site, ensuring compliance with FDA and EU GMP regulations while supporting operational excellence.

The ideal candidate will have over 15 years of experience in scientific or quality assurance roles and a strong understanding of cGMPs. Ardena offers a collaborative work environment and competitive salary, along with various benefits.

Qualifications

• 15+ years of scientific or QA/QC experience required.
• Experience in driving quality culture and compliance.
• Ability to balance compliance, cost, and customer expectations.

Responsibilities

• Ensure compliance with regulatory and internal standards.
• Oversee batch certification and deviations.
• Drive quality improvements and culture.

Skills

cGMP understanding

Communication skills

Team collaboration

Organizational skills

Problem-solving skills

Education

BS or BA in Chemistry, Biological Sciences, or related field

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.

Ardena 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 U.S. facility is based in Somerset, New Jersey.

For the Ardena Business Unit based in Somerset (U.S.), we are looking for a Site Quality Director.

Job Overview

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 continous 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, 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, and regulatory approvals.
• Contribute to client interactions and proposals, ensuring quality positioning is competitive and credible.
• Drive measurable improvements in cycle time, Right‑First‑Time performance, Cost of Poor Quality (COPQ), and lead initiatives to simplify processes while maintaining compliance.
• Build, lead, and develop a high‑performing quality organization.
• Foster a culture of accountability, ownership, and 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 verbally and written.
• Cooperates with co‑workers; is a team player and willing to contribute to team activities.
• Demonstrates flexibility in organizing work and priorities.
• Excellent organizational skills related to management of associates’ daily activities.
• Excellent problem‑solving 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

• 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 U.S. 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: $155,000 - $185,000

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