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

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.

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

Site Quality Director

Key skills