Covance Associate Director, Compliance Management in Dallas, Texas

Job Overview

This position can be home based or office based anywhere within the United States.

  • Manages, trains and develops the staff of the Compliance Management Department

  • Ensures the CAPA Management processes are robust and followed

  • Ensures all non-compliances are documented, investigated and corrected efficiently

  • Provides history (or a Body of Knowledge) regarding CAPA implemented and their efficiency

  • Identifies trends/signals from all non-compliances and CAPAs

  • Prepares training programs based on CAPAs (Lessons Learned)

  • Participates actively in the improvement of processes with functional units

  • Provides consultation to functional units

  • Participates in regulatory inspections or sponsor audits regarding CAPAs, trends and continuous improvement projects

  • Be acquainted to legislations, regulations, guidelines, Covance Quality System, Sponsor requirements and inspection trends and signals and links with Regulatory Intelligence

  • Ensures the quality and integrity of the documentation of non-compliance by overseeing all non-compliance in CAPA Management system/process

  • Ensures the quality and integrity of CAPAs requests by overseeing the appropriate classification, assessment and uniformity between CAPA Managers

  • Oversees the process of CAPA approval to ensure sound investigation, root cause analysis and appropriate metrics for proof of efficiency (level of action) and uniformity between CAPA Managers

  • Reviews the CAPA closure to ensure the documentation would sustain the scrutiny of an inspector or auditor

  • Oversees the efficiency and robustness of the CAPA Management processes

  • Ensures all compiled non-compliances build a Body of Knowledge on Covance processes allow demonstration and assessment of efficiency and continuous improvement

  • Participates in the trending of and signal detection from non-compliances

  • Oversees the creation of Global CAPA on trends or signals identified

  • Communicates and discusses with functional units results of trending and signal detections of identified non-compliances and identifies Continuous Improvement Plans

  • Oversees the creation of Lessons Learned Training Modules on a quarterly basis for CRAs, CTLs and auditors

  • Works with CAPA Managers to create specific training modules or discussion for Global CAPA or serious non-compliance

  • Oversees that CAPA Management provides auditors with risks that they can focus on during audit (Risk-based audits)

  • Participates in the review of the final draft of CDs to ensure (1) they are compliant with regulations/guidelines, regulatory agencies actual position and Covance Quality System and (2) they are consistent with the Body of Knowledge built with the review, trending and signal detection of CAPAs

  • Maintains Compliance Quality System

  • Participates in regulatory inspections or sponsor audits regarding CAPAs, trends and continuous improvement projects

  • Contributes to process improvement across the Organization

  • Manages, trains and develops the staff of the Compliance Management Department

  • Keeps records on CAPA Managers performance

  • Perform any required tasks as requested

Education/Qualifications

Minimum Required:

• Minimum university/college degree, BA/BS

• Knowledge of international drug development legislations, regulations, guidelines (ICH E6)

• Management skills

• Analytical skills

• Process improvement oriented

• Proven interpersonal skills and ability to negotiate and influence

• Oral, written and presentation skills

Preferred:

• Experience with TrackWise, Master Control or other issue/deviation management systems

• Lean Six Sigma certification or experience

Experience

Minimum Required:

  • Seven to ten years in Quality Assurance or Compliance

  • Experience in auditing

  • Experience with Regulatory inspections

Job Number 2018-21935

Job Category Quality Assurance

Position Type Full-Time

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