MANAGER, QUALITY ASSURANCE (GCP)

MANAGER, QUALITY ASSURANCE (GCP)

Secaucus, NJ

Duties: Responsible for the quality management of a Phase I/IIA clinical research center (CRC) operated by Frontage Clinical Services, Inc. (FCS) and Biostatistics and Data Management Consulting, Inc. (BDM)

Works with Operations Management and Investigators to design and implement a robust quality system to comply with GCP regulations and standards

Independent oversight of the GCP quality systems achieved by performing planned systematic actions to ensure that activities performed comply with applicable laws and regulations, and that study protocols are being followed using approved operating procedures

Domestic and international travel may be required

Qualifications:

  • Degree in Nursing, Science, or related field (or equivalent)
  • Strong GCP knowledge and experience in Clinical Quality Assurance
  • Working knowledge of the drug development process, GCP, GLP, GMP and ICH guidelines, and FDA regulations
  • Computer literate in Microsoft Office, Word, Excel and Power Point
  • Excellent organizational and time management skills
  • Outstanding interpersonal, communication and writing skills

Experience:

  • Minimum of five (5) years of clinical research experience in pharmaceutical, biotech, medical device and other life science industries or equivalent education and experience
  • Management experience desired

 Specific Responsibilities:

  • Conducts independent quality internal review of studies performed and ensures the conduct of clinical systems audits are performed per audit plan
  • Oversees and advises on the development of Standard Operating Procedures, Guidelines and other tools
  • Performs external non-Frontage investigational sites audits (as needed) for compliance with GCP and ICH guidelines, applicable FDA regulations, SOPs, and the study protocol
  • Hosts regulatory agency inspections/sponsor audits and issues responses to audit report findings after discussion with operations management
  • Works with quality team and management to ensure internal and external audit findings are addressed, deficiencies are corrected and preventive actions are implemented
  • Leads study conduct investigations and non-conformance issues. Develops, recommends and monitors Corrective and Preventive Action Plans (CAPAs). Performs effectiveness verification to ensure CAPAs were implemented
  • Tracks and trends audit findings, investigations, assesses compliance risk and escalates to site management appropriately
  • Initiates and manages quality metrics and trending analysis, and presents findings to management appropriately
  • Updates department management on new/updated regulations affecting CRC operations and provides training as appropriate 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 for the development of company policies and procedures
  • Other responsibilities as assigned

 

 

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