Director, Clinical Quality Assurance

Openwork; Nutley (NJ); On-site; USD 195,000 - 256,000; Full time

Job summary

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.

Qualifications

• 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%).

Responsibilities

• 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.

Skills

GCP auditing

Audit management

Regulatory knowledge

Stakeholder collaboration

Quality systems

Data integrity controls

Education

Bachelor's degree in a related field

Advanced degree preferred

Tools

Computer system validation

Quality management systems

Job description

Director, Clinical Quality Assurance

The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Company’s Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).

Responsibilities

• 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.

Requirements

• Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research or operations or related area. Prior experience in site monitoring and study management is preferred.
• Strong knowledge of multiple therapeutic areas, eg. 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 and guidelines for the conduct of clinical trials.
• Demonstrated ability to effectively influence and collaborate with senior stakeholders, maintaining Quality’s independence and authority in challenging and high-pressure situations.
• Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
• Knowledge of data integrity controls and systems quality for clinical area
• Strong analytical skills and report writing skills
• Knowledge of GxP systems including computer system validation and associated regulations, recommended.
• Ability to Travel (approximately 15%)

Base salary range: $195,000 -$256,000 per year. This is the anticipated salary range for fully qualified candidates. The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry, education, etc.