Our client located in Hudson County, NJ is seeking a Quality Assurance Manager for their Clinical Operations Group. The ideal candidate will have a Bachelor’s degree in a scientific field and a minimum of 5 years of experience in a CRO environment.

Location: Hudson County, NJ
Type: Direct hire

Qualifications:

• Bachelor's degree in Science, Nursing, or a related field.
• Proficient understanding of GCPs, ICH guidelines, and FDA regulations pertinent to Clinical Research, along with demonstrated experience in Clinical Quality Assurance.
• Familiarity with the drug development process, GLPs, and GMPs.
• Knowledge of ISO 27001 is advantageous.
• Understanding of 21 CFR Part 11 and validation of computer systems.
• Proficient in Microsoft Office suite, including Word, Excel, and PowerPoint.
• Outstanding organizational, communication, writing, and time management skills.

• Minimum of five (5) years of experience in clinical research within CRO pharmaceutical, biotech, medical device, or other life science industries, or an equivalent combination of education and experience.

• Conducts independent internal quality reviews of conducted studies and ensures clinical systems audits are conducted according to the audit plan.
• Oversees and provides guidance on the development of Standard Operating Procedures (SOPs), Guidelines, and other relevant tools.
• Performs external audits at investigational sites (as required) to ensure compliance with GCPs, ICH guidelines, FDA regulations, SOPs, and study protocols.
• Facilitates regulatory agency inspections/sponsor audits and formulates responses to audit report findings following discussions with operations management.
• Collaborates with the quality team and management to address internal and external audit findings, rectify deficiencies, and implement preventive actions.
• Leads investigations into study conduct and non-conformance issues, formulating and monitoring Corrective and Preventive Action Plans (CAPAs), and ensuring their effectiveness.
• Tracks and analyzes audit findings and investigations, assesses compliance risks, and escalates them to site management as necessary.
• Initiates and manages quality metrics and trending analysis, presenting findings to management appropriately.
• Keeps department management informed of new or updated regulations affecting CRC operations and provides training as necessary to ensure ongoing compliance with current quality and industry regulatory requirements.
• Reviews and approves computer systems validation (CSV) documents (when applicable) to ensure compliance with internal procedures and regulatory requirements.
• Evaluates procedures and processes affecting quality and proposes process improvement initiatives.
• Represents clinical Quality Assurance as a management representative in the development of company policies and procedures.
• Performs any other duties as assigned.