Associate Director, Quality Assurance Systems & Data Integrity

Associate Director, Quality Assurance Systems & Data Integrity

Direct Hire

Location: Remote or On-Site, but local candidates only!

This role can be on-site in Bergen County, NJ (once permissible) OR remote for candidates who can commute to this location as needed, with short notice.


Job Summary

The Associate Director, GCP Quality Assurance Systems & Data Integrity, will oversee quality oversight activities of Clinical Trial Systems used by Company, Vendors & CROs and lead associated audits and inspection management.

This person will manage cross-functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to IT and associated vendor management. This is a high visibility position with great impact potential.

Essential Functions

•Lead the conduct of internal clinical System/Process audits and Data Integrity & Access Governance (DIAG) audits as needed.
•Lead the conduct of clinical vendor audits of CROs, laboratories, and other providers to clinical trials by conducting remote audits or on-site audits (as deemed necessary) in the Americas, following company procedures and practices, to verify data integrity, GCP compliance with ICH guidelines and government regulations/guidance.
•Support health authority inspections and preparation activities related to IT aspects
•Compile and analyze audit metrics to communicate trends to business group


Bachelor’s degree in associated functional disciplines including IT, Data Sciences, Pharmaceutical Science and others
•8+ years of pharmaceutical company experience preferably in Clinical Data Management, Clinical Systems or related area.
•Minimum of 3-6 years of Quality Assurance auditing experience with at least 2 years conducting Systems and clinical vendor audits
•Experience with inspection management including leading inspection strategy
•Knowledge of general GCP, clinical trial methodology, and specific knowledge of applicable regulations/guidance (including 21 CFR Part 11) and ICH Guidelines related to clinical computer systems

•Clinical systems orientation with familiarity of emerging technologies such as cloud computing, mobility, and big data and its applicability to clinical research
•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 20%)

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