Jobid=3201556676
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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