|Reference # : ||17-00692
||Title : ||Process Control Manager|
East Hanover, NJ
|Experience Level : ||
||Start Date / End Date : ||10/02/2017 / 10/02/2018
| Description |
|The PCM is responsible for process control and improvement in TMo, focused on Good Clinical Practices (GCP).|
The role works collaboratively across the Monitoring Organization and with CQA to ensure improvement of quality and completion of risk management activities.
The PCM conducts reviews of GCP audit and inspection findings to identify trends and systematic gaps in the monitoring processes.
Tracks progress to Key Performance Indicators (KPIs) that impact quality, Quality Plan and overall compliance to applicable monitoring processes, regulations and training requirements.
Facilitates the development and implementation of quality improvement initiatives within the Monitoring Organization; ensures process changes are adequately communicated and managed; inputs into the development of new processes and SOPs that contribute to sustainable quality.
A minimum of 5 years in a R&D regulated environment in a relevant pharmaceutical or health care company, desirable clinical operations experience
Experience in ICH-GCP Process Control or ICH-GCP Quality Assurance systems and Health Authority regulations; Clinical Operations experience in these areas is preferred Demonstrated ability for leading initiatives with cross-functional teams and implementation of recommendations
Experience working in matrix environment and in global teams
Excellent interpersonal, problem-solving, negotiation and conflict resolution skills
Excellent organizational skills, as well as predisposition to quality management and process improvement
Excellent communicator and presenter (oral and written)