What are the responsibilities and job description for the Director Quality Standards and Training position at acorda_therapeutics?
The Director - Quality Standards and Training is responsible for the oversight of all aspects of Drug Safety and Risk Management (DSRM) functions, including assurance of compliance and investigative activities. This individual is responsible for the development, implementation and oversight of quality activities in support of DSRM. These activities include, but are not limited to the following : Audit / Inspection Readiness, Training Oversight, PV Deviation Investigation Management, Ad-hoc / Aggregate Report QC, ICSR QC, PV Intelligence, PV Agreement Maintenance, Key Performance Indicators, Process Improvement, Vendor Oversight and DSRM Documentation Management.
If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.
- ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Develops strategy and vision to set departmental standards for quality and training.
- Provides a compliance evaluation and review function for DSRM procedures.
- Develops and reports Pharmacovigilance compliance metrics related to DSRM activities.
- Determines escalation procedures for issues arising from DSRM and drives DSRM and cross-functional process improvement activities.
- Ensures the development, documentation, and tracking of corrective and preventative actions (CAPAs) to address DSRM compliance risks.
- Responsible for the development, implementation, and oversight of measures that manage compliance of external groups that impact DSRM deliverables (contractual partners, vendors, client groups, CROs, etc).
- Ensures DSRM readiness for pharmacovigilance inspections and audits.
- Collaborates and partners with Acorda Quality department to ensure the effective management and conduct of audits and inspections and to promote a successful PV Quality Management System.
- Facilitates the development of cross –functional CAPAs to address PV-related observations cited in audits and inspections.
- Serves as the DSRM point of contact for Acorda Quality matters pertaining to PV-related quality assurance activities.
- Establishes and maintains effective cross - functional team communications to advance Acorda’s quality activities and promote best practices.
- Maintains a contemporary knowledge of current industry trends, standards and methodologies relating to PV quality management and ensures sound application within the department.
- Develops and presents summaries on quality issues, initiatives and projects at cross functional meetings.
- Serves as a strategic and technical expert for production of PV quality metrics and compliance reports.
- Develops, maintains, and ensures the effectiveness of SOPs and instructions related to DSRM Quality Standards and Training function.
- Develops and implements measures to oversee DSRM training compliance and effectiveness.
- Provides ongoing performance review, feedback and development of staff.
- Assists with talent recruitment and leads a highly motivated, efficient and effective team.
- Responsible for training and mentoring associates on the Drug Safety Team.
EDUCATION AND / OR EXPERIENCE :
SUPERVISORY RESPONSIBILITIES :
QUALIFICATIONS :
COMPUTER SKILLS :
CERTIFICATES, LICENSES, REGISTRATIONS : none required
OTHER SKILLS AND ABILITIES :
PHYSICAL DEMANDS :
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
WORK ENVIRONMENT :
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
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