Safety Compliance Manager (Office-Based) - IQVIA Biotech (R1099177) in Morrisville, NC at IQVIA™

Date Posted: 10/7/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    10/7/2019
  • Job ID:
    R1099177

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

IQVIA Biotech is seeking a Safety Compliance Manager (Office Based in Morrisville, NC preferred) - focus on audit readiness and quality control.

BASIC FUNCTIONS:

Coordinates and oversees safety departmental quality control processes and efficiency checks.

Ensures consistent audit readiness for all safety functional areas

Coordinates audit preparations of all involved staff and supports internal audits and client audits as needed

Ensures fully compliant documentation of applicable procedures documenting internal quality control

Coordinates the assessment of quality issues and participates in the determination of applicable process improvements

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Assists Safety Leadership (Assoc Director level & above) with designing and planning the Quality Control and Quality Management strategy of the Safety Management Department.
  • Implements Safety Management Department Quality Control strategy through development of metrics and KPIs in collaboration with safety systems and safety management staff.
  • Regularly reviews quality metrics, provides feedback to management and supports applicable follow up actions as requested
  • Provides guidance and instructions to Safety Management staff as needed, e.g. for metrics generation and evaluation.
  • Organizes and regularly delivers prep sessions for project teams to ensure audit readiness at all times
  • Coordinates process and manages timelines for safety related CAPA including monitoring of internal timelines, support of safety staff in Root Cause Analysis and liaison with corporate QA for follow up activities
  • Coordinates and participates in project and functional quality review process as applicable, provides feedback and ensures consistent documentation
  • Writes and/or provides input to department specific SOPs and Working Practices.
  • Communicates regular updates and promptly escalates any issues or concerns related to quality issues or staff performance to applicable Safety Leadership.
  • Performs other related duties as assigned or requested by the Safety Leadership.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Robust knowledge of the clinical research process, safety processes and terminology.
  • Robust expertise in Quality Management principles
  • Proven experience in CAPA generation and follow up process including Root Cause Analysis required
  • Experience in utilizing a variety of technical systems and tools to successfully retrieve and evaluate compliance data
  • Proven experience in coordination of audits and inspections required
  • Excellent ability to communicate in a global and remote environment
  • Positive attitude and ability to interact effectively with all levels of staff.
  • Excellent organizational and interpersonal skills.
  • Considerable initiative, independent judgment, and discretion
  • Outstanding attention to detail required
  • Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
  • Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
  • Independently prioritizes time effectively based on department needs. Consistently meets deadlines.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Ability and willingness to travel domestically and internationally
  • Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor's Degree in one of the life sciences or clinical research or related field required.
  • Minimum of 7 years of relevant experience in Clinical Research, Quality Management, Safety.
  • Equivalent combination of relevant education and experience.
  • Advanced computer literacy and skills in working with Microsoft Office (Word, Excel, PowerPoint, Visio) required
  • Knowledge of electronic data capture systems and safety database systems.
  • Excellent verbal and written communication skills required. 
  • Excellent interpersonal and organizational skills required.
  • Ability to work independently, prioritize effectively and work in a matrix team environment required. 

CLASSIFICATION:

This position is classified as exempt from the Fair Labor Standards Act; employees are not eligible for overtime compensation.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1099177