The Manager of GCP Quality is responsible for supporting the independent Quality oversight of internal and external Good Clinical Practices (GCP) and assuring compliance of projects with applicable worldwide regulations and guidelines (e.g. FDA, EMA, ICH, national regulators). This position is also responsible for providing support for upgrading and maintaining systems to oversee GCP compliance programs as the company evolves towards late stage and commercial activities.
location: Bridgewater, New Jersey
job type: Permanent
salary: $80,000 - 90,000 per year
work hours: 9 to 5
- Assess compliance of clinical trial activities, including clinical investigator sites, study data, and reports against FDA & ICH GCP Regulations
- Perform GCP audits including audits of clinical investigator sites, clinical trial master files, and clinical summary reports Perform GCP qualification audits of CROs, Phase 1 Units, and Vendors Communicate audit outcomes and potential impact of deficiencies
- Act as a technical resource to resolve GCP issues based on knowledge of regulations, guidelines, and relevant SOPs
- Provide support and revise as needed, an effective GCP training program Proactively identify quality issues/discrepancies; communicate, and effectively resolve issues in collaboration with internal and external partners
- University degree in life sciences or related fields
- BS/MS with relevant experience desired
- Expertise in GCP regulations and guidance of Health Agencies and ICH guidelines
- Able to influence peers, team-members, and other key stakeholders; experienced team participant and team builder
- 5-8 years of direct experience in GCP Quality Systems and oversight of drug development lifecycle, clinical research, clinical study monitoring, or pharmacovigilance GVP and/or GLP experience is a plus.
- Must have excellent attention to detail, time management and investigative skills, as well as ability to manage multiple priorities with aggressive timelines
- Must have strong written and oral communication skills
- Working knowledge of computer software to perform trending and prepare presentations (MS Word, MS Excel, MS PowerPoint, etc.).
- Familiarity with various eDC and eTMF platforms is a plus
skills: GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.