Site Quality Director

Ardena Careers

Site Quality Director at Ardena driving end-to-end GMP compliance in Somerset, NJ. Leading quality improvements and developing a high-performing team for patient-focused growth.

Posted 5/28/2026full-timeSomerset • New Jersey • 🇺🇸 United StatesLead💰 $155,000 - $185,000 per yearWebsite

About the role

Key responsibilities & impact

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)
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

Requirements

What you’ll need

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
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

Benefits

Comp & 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 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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

batch certificationdeviationsCAPAchange controlcomplaintsrecallsvalidationqualificationquality risk managementcGMP

Soft Skills

communicationorganizational skillsproblem-solvingdecision-makingflexibilityaccountabilityownershipcollaborationcoachingleadership