Pharmaceutical Clinical Associates, LLC
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Raritan,
NJ
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Defines metrics for continuous quality improvement actions, facilitates continuous improvement and the analysis of audit and inspection trends to drive the identification of risk areas, compliance issues, and opportunities for each of the functional lines in QA.
• Uses QA databases and input from QA colleagues, stakeholders and customers to monitor trends, identify compliance issues and/or opportunities for improvement, and to assess/measure quality improvement.
• Coordinates relevant regulatory inspections and responses to inspections observations.
• Partner with Safety for Pharmacovigilance inspections.
• Develops Inspections readiness tools and support the implementation of the GCP/PV inspection readiness program.
• Liaises with relevant SOP and Training groups to promote continuous quality/process improvements across Development, Medical and Safety.
• Evaluates audit/inspection reports from various sources (e.g., regulatory agencies, other Company quality groups) to identify issues of significance and reports trends.
• Establishes process and maintains oversight of global metrics generation and analysis.
• Manages the compilation of QA functional line guidance documents and audit tools.
• Interfaces with functional groups within GCQA and customers to build knowledge of GCP/Pharmacovigilance (PV) regulations and guidelines, and routinely engages in influencing the external environment through appropriate QA activities (e.g. review of guidelines).
• Trains Clinical Auditor to use QI tools and techniques (e.g. RCA / Kaizen / Six Sigma).
• Plans, leads, and ensures continuous quality improvement initiatives to completion and carries out corrective actions, as needed.
Experience and Skills:
Bachelor’s degree is required. Advanced degree desirable. Equivalent relevant professional experience may be considered.
• Substantial experience in clinical QA or other clinical quality management/QC role in biomedical science, clinical development, regulatory compliance.
• Prior experience in organizations or with applications for continuous improvement or metrics trending highly desirable.
• Demonstrated knowledge of ICH GCP, PV, clinical development and principles of quality assurance is essential.
• Demonstrated knowledge/expertise in continuous improvement with background in appropriate tools/processes e.g. strong quality orientation and understanding of metrics; Lean Six Sigma training; demonstrated knowledge of Root Cause Analysis techniques.
• Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
Additional Information:
Job Level: Management
Number of Openings: 1
Years of Experience:
Level of Education: BA/BS
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Raritan, NJ
Raritan, New Jersey
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