We're looking for a Clinical Quality Consultant, working in the Pharmaceuticals & Medical Products industry in Woodcliff Lake, New Jersey, United States.
Supports cross-functional colleagues in the development of responses for internal system audits and regulatory inspections that address identification of actual root cause and improvements needed to support preventing finding in future.
Leads a group of process and system owners in reviewing quality oversight data related to critical processes to identify gaps in standards, procedures and technologies that are a risk to clinical trial quality
Works with cross-functional teams to develop, prioritize and implement quality plans based on the prospective data to reduce/mitigate risk to clinical trial quality.
Participates in and/or lead forums and process improvement/system initiatives related to critical quality processes such as essential document management, data management, trial management, investigational product management, etc.
We are offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Bachelor’s Degree in relevant health care area; Master’s Degree preferred.
Minimum 8 years in the pharmaceutical or biotech industry and at least 5 years of direct experience in GCP auditing and inspections and 3 years in Clinical Development or Operations managing or supporting clinical trials for Associate Director level.
Minimum 5 years in the pharmaceutical or biotech industry and at least 3 years of direct experience in GCP auditing and inspections and 1 years in Clinical Development or Operations managing or supporting clinical trials for Manager level.
Prior experience in root cause analysis, risk assessment, and prospective indicators of quality issues is desired.
Knowledge and understanding of clinical development programs, clinical trial processes as well as quality management and control tools is required.
Experience in Oncology therapeutic area, specifically related to design of trials and therapeutic area knowledge preferred.
Experience developing and delivering effective CAPA management solutions.
Project management and organizational skills.
Ability to analyze, interpret, and solve complex problems.
Ability to think strategically and objectively and with creativity and innovation.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.