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.

_*_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:

• Bachelor’s degree in a scientific, allied health field or related field required.
• Master’s degree in a scientific allied health field or related field preferred.
• A minimum of eight to ten years of relevant work experience required.
• Minimum of five to seven years of progressive experience serving in a Quality role in the pharmaceutical/biotechnology or related industry dealing with Good Pharmacovigilance Practice (GPvP) activities, including quality related matters, and experience in conducting audits and hosting GPvP regulatory inspections.

SUPERVISORY RESPONSIBILITIES:

• This position supervises one or more Drug Safety Quality Monitors.
• Provides guidance to subordinates based on organizational goals and company policies.

QUALIFICATIONS:

• Demonstrates broad and deep expertise related to understanding the principles and application of quality and regulatory compliance.
• Strong knowledge of worldwide regulations pertaining to GPvP for pharmaceutical products, including FDA, ICH and EU GVP.
• Strong knowledge and experience in auditing and inspections, including development of responses.
• Prior experience in the management, development and implementation of a risk-based global PV & QA Audit program in support of clinical safety and pharmacovigilance activities.
• Advanced knowledge of quality management systems, including systematic approaches to process improvement (ie. Six Sigma) required.

COMPUTER SKILLS:

• Must be proficient in MS Office Suite.
• Knowledge regarding the use of electronic systems in a regulated environment, including those implemented in support of drug safety, training oversight, and documentation management.

CERTIFICATES, LICENSES, REGISTRATIONS: none required

OTHER SKILLS AND ABILITIES:

• Excellent written, communication, and presentation skills.
• Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.
• Demonstrated leadership and project management skills.
• Advanced ability to effectively communicate and influence the outcomes of the decision making process.
• Displays highly developed organizational leadership qualities.
• Must demonstrate a keen attention to detail and timelines.
• Demonstrated leadership and project management skills.
• Demonstrated ability to stay abreast of trends and new information in the profession.
• Ability to maintain a high level of ethical and compliancy standards.

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.

• This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives. Travel is for meetings and conferences.

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.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.