Associate Director - Quality Standards and Training
Acorda Therapeutics - United States

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The Associate 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, PV Deviation Investigation Management, Ad-hoc/Aggregate Report QC, ICSR QC, Reconciliation, PV Intelligence, PV Agreement Maintenance, and DSRM Documentation Management. PLEASE REFER TO JOB CODE 10612 WHEN APPLYING FOR THIS POSITION

  • Essential Duties and Responsibilities include the following. Other duties may be assigned.:
  • 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 process improvement activities.
  • Tracks corrective and preventative actions (CAPAs.)
  • 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 readiness for pharmacovigilance inspections and audits.
  • Establishes and maintains effective cross - functional team communications to advance quality activities of Acorda and promotes 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.
  • May conduct presentations on quality issues, initiatives and projects at cross functional meetings.
  • Develop SOPs and instructions related to DSRM Quality Standards and Training function.
  • Undertakes 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 seven to nine years of relevant work experience required.
  • Minimum of three to four years 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.
  • Sound knowledge of worldwide regulations pertaining to GPvP for pharmaceutical products.
  • Knowledge and experience in auditing.
  • 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.
  • Excellent analytical problem solving attitude, influencing and interpersonal relationship skills.
  • Advanced knowledge of quality management systems.
Computer Skills::
  • Must be proficient in MS Office Suite.
  • Knowledge regarding the use of electronic systems in a regulated environment.
Certificates, Licenses, Registrations::
None required

Other Skills and Abilities::
  • 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.
  • Excellent writing, communication, and presentation skills.
  • 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.
Location: Corporate Office (Ardsley, NY):
This position requires the ability to work on site 5 days per week in the Corporate Office in Ardsley, NY.

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 will travel occasionally for meetings and conferences – approximately 5-10 percent.
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.