Associate Director Quality Gcp (Good Clinical Practice)

1.Associate Director Quality GCP –( this is someone who audits clinical research and nothing else).

Notes:

have to have GCP (Good Clinical Practice) audit and inspection experience, ask that question

30% travel vendor site or less

good personality/best practices

lead people/build team—will be building a team in the future

Description:

Job Summary

The Associate Director, GCP Quality Assurance oversees GCP activities at The company, our CROs and Investigator Sites, leads GCP audits and inspection readiness. The successful hire will ensure high quality execution of clinical trials from first in human through commercial marketing authorization of clinical trials. This person will manage cross functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams. This is a high visibility position with great impact potential.

Responsibilities

Proactively provide GCP QA support for clinical development activities to protect patient safety & wellbeing, maintain data integrity, and support operational excellence

Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and support Vendor/System audits

Author and manage Audit Plans and Audit reports

Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams

Manage health authority inspection preparation activities and provide leadership and oversight during inspections

Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)

Compile and analyze audit metrics to communicate trends to business groups

Conduct GCP training sessions for business groups

Manage direct reports (if applicable)

Requirements

Bachelor's degree in associated functional discipline, advanced degree preferred

Preferably 8+ years' experience in Clinical research/ operations/data management or related area. Minimum of 3-6 years of Clinical Quality Assurance auditing

Technical and administrative capabilities to independently carry out routine, complex and for-cause audits

Experience of inspection management

Experience with supervising direct reports preferred

Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials

Strong analytical skills and report writing skills

Ability to demonstrate tact as a representative of the CQA Department

Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently

Ability to Travel (approximately 25%)

Flexible job location. Remote within about two to three hours from Nutley NJ so if they do need to come in its not a long drive