Director, Clinical Quality Assurance

Pharma Search Partners, LLC; Nutley (NJ); On-site; USD 150,000 - 190,000; Full time

Job summary

Pharma Search Partners, LLC seeks a Director, Clinical Quality Assurance in Nutley, NJ to design, deliver, and execute the NA CQA strategy, including audit and inspection management and SOP compliance. This role ensures GCP oversight across projects, products, and programs with global regulations and guidelines.

Responsibilities include leading CQA audits of sites and vendors, facilitating sponsor inspections, and developing staff through cross-functional partnerships, while maintaining Quality

Qualifications

• Bachelor's degree in a functional discipline; advanced degree preferred.
• 5+ years in clinical research/operations or related area.
• Experience in GCP auditing and inspection management.
• Knowledge of US/EU/international regulatory standards for clinical trials.

Responsibilities

• Independently conduct audits across sites, vendors, and processes.
• Oversee CQA audits of study sites, vendors, documents, and internal processes.
• Facilitate sponsor health authority inspections of global facilities and study sites.
• Provide skill-building for CQA staff through cross-functional partnerships.

Skills

GCP auditing

Audit management

Regulatory knowledge

Data integrity controls

Analytical skills

Report writing

Stakeholder influence

Education

Bachelor's degree in a related field

Advanced degree preferred

Job description

Please review the listings below of currently available job openings.

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 Client’s Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).

Essential Functions

• 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.

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.