Site Quality Director

Ardena • Franklin Township, NJ

10d • $155,000 - $185,000 • Onsite

About The Position

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.

Requirements

• BS or BA in Chemistry, Biological Sciences, or other related scientific discipline or equivalent experience.
• 15 + years of Scientific or Quality Assurance and/or Quality Control Experience
• 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

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior