Director, Clinical Quality Assurance & Audit Strategy

Openwork LLC; Nutley (NJ); Presencial; USD 195.000 - 256.000; Jornada completa

Descripción de la vacante

Openwork LLC in Nutley, New Jersey, seeks a Director of Clinical Quality Assurance to design and execute the NA CQA strategy, overseeing audits, inspection readiness, and the Quality Management System in accordance with US/EU/ICH guidelines.

The role requires 12+ years in clinical research, GCP auditing, and strong regulatory knowledge, with travel up to 15%. Base salary range is 195,000–256,000 USD per year, and final offer depends on experience and qualifications.

Formación

• Bachelor’s degree in a related field with minimum 12 years in clinical research or operations.
• Strong knowledge across therapeutic areas (e.g., neuroscience and oncology) and ability to translate key protocol objectives into auditable activities.
• 5+ years of experience in GCP auditing.
• Substantial experience in inspection management.
• Substantial experience with US, EU, and international regulatory standards for clinical trials.
• Demonstrated ability to influence and collaborate with senior stakeholders while maintaining Quality independence.
• Knowledge of data integrity controls and GxP systems in clinical area.
• Ability to travel (approximately 15%).

Responsabilidades

• Independently conduct audits.
• Oversee and guide conduct of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits.
• Facilitate Sponsor health authority inspections of global clinical facilities and study sites.
• Provide skill-building interventions for CQA staff through cross-functional/external partnerships to reskill/upskill and adapt the workforce to evolving technologies.
• Potential for direct people management.

Conocimientos

GCP auditing

Audit management

Regulatory knowledge

Stakeholder collaboration

Quality systems

Data integrity controls

Educación

Bachelor's degree in a related field

Advanced degree preferred

Herramientas

Computer system validation

Quality management systems

Descripción del empleo

Openwork LLC in Nutley, New Jersey, seeks a Director of Clinical Quality Assurance to design and execute the NA CQA strategy, overseeing audits, inspection readiness, and the Quality Management System in accordance with US/EU/ICH guidelines.

The role requires 12+ years in clinical research, GCP auditing, and strong regulatory knowledge, with travel up to 15%. Base salary range is 195,000–256,000 USD per year, and final offer depends on experience and qualifications.