Director, Contract Testing Laboratories Quality Oversight

Over de vacature

Overview

In this role you drive the strategic quality oversight of external contract testing laboratories and cell banking operations to ensure GLP/GMP compliance, patient safety, and regulatory readiness. You lead a global quality function, partnering with external labs to protect product integrity and enable reliable launches. You will shape risk-based oversight, resolve quality issues, and mentor a high-performing team in a complex, regulated environment. This is a chance to influence quality governance across the contract testing network and accelerate remediation as needed.

Arbeidsvoorwaarden / Benefits

• medical, dental, vision insurance
• retirement benefits (401(k
• paid holidays
• vacation and sick days
• flexible benefits package
• compensation with bonus/long-term incentives (where applicable)

Verantwoordelijkheden

• Lead strategy, organisation design, budget oversight and performance management for CTLs and cell bank quality oversight
• Establish a risk-based quality oversight model for CTLs and for cell banking
• Provide operational leadership for drug substance, drug product and finished product testing
• Oversee quality compliance of CTLs with regulatory expectations and GLP/GMP requirements
• Oversee quality issues, OOS investigations, and deviations impacting launch or supply continuity
• Lead analytical technology transfer quality oversight
• Define performance metrics and governance routines to monitor quality and operations
• Lead quality assessments for prospective CTLs or new method candidates and remediate gaps
• Establish and maintain quality agreements to protect company quality and compliance
• Direct, mentor, and develop a high-performing QA team dedicated to external testing oversight
• Foster a culture of accountability, collaboration, operational excellence, and proactive problem-solving across internal and external networks

Belangrijkste vereisten

• Minimum of ten (10) years in Quality Systems/QA/QC within pharmaceutical manufacturing under global GMP and health authority requirements

• Proven track record managing complex quality investigations, risk assessment, and data-driven decisions

• Strong compliance background with experience supporting regulatory inspections and health authority interactions

• Demonstrated success leading and developing teams

• Ability to travel 30% of the time, including short-notice travel

• leadership and people development

• collaboration and cross-functional influence

• problem-solving and decision-making

• quality governance models

• supplier oversight and risk-based quality management systems

• external partner leadership (biologics/vaccines)

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