Site Quality Director (Somerset New Jersey)

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.