Associate Director, Clinical Quality Assurance, Systems & Data Integrity
NOW HIRING! Associate Director, Clinical Quality Assurance, Systems & Data Integrity in Woodcliff Lake, NJ
19th July, 2020
Job Type: Direct
The pharmaceutical industry is NJ's top industry and recession-proof. Very stable environment.
Our client is a premier, nationally recognized Pharmaceutical company looking to hire a Associate Director, Clinical Quality Assurance, Systems & Data Integrity.
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