Worldwide Clinical Trials

Director, Quality Assurance

Location
Serbia (RS)
Salary
up to 50,000 per annum
Posted
23 Jun 2019
Closes
23 Jul 2019
Ref
QATL
Discipline
Quality, GCP
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

SUMMARY: The QA Clinical Program head is responsible for the oversight, planning, execution, reporting and quality management for assigned Therapeutic Areas within the QA Clinical Oversight Program. This position reports directly to the EVP Global Head of Quality.
 
RESPONSIBILITIES:

  • Serves as the Subject Matter Expert (SME) for Quality Issues (QIs) and Corrective and Preventive Action (CAPA) Management
  • Drives process improvements for processes as related to the Quality Oversight Program inclusive of QI/CAPA Management, inclusive of training
  • Monitor, tracks, and reports on Key Quality Indications (KQI) and Quality Tolerance Limits (QTL) for the assigned Therapeutic Area(s)
  • Develops QA Clinical Oversight Budget annually
  • May serve as the delegate to the EVP Global Head of Quality as necessary
  • Serves as an ambassador of the QA organization with internal and external customers
  • Participates in the crafting of the QA organizational goals and objectives as assigned
  • Plans and manages all resources (budgets, staff, and technologies) for the advancement of the QA’s goals and objectives for the QA Clinical Oversight Program
  • Leads a team of Quality Professionals to oversee the delivery of quality deliverables, on time, and in compliance with regulations and Worldwide processes
  • Approves work-related travel and expenses reports for direct reports while staying on budget and in compliance with Worldwide Travel Policy
  • Ensures compliance with Worldwide’s’ Quality Management System (QMS)
  • Champions and adheres to Worldwide’s Quality Management System (QMS)
  • Leads regular Issue Management meetings with Functional Area Representatives and delivers reports on trends to the Pulse on Quality Representative.
  • Leads/Participates in the development and review of Quality Management Documents
  • Develops training materials and/or delivers training as requested
  • Participates in risk assessments of Protocols, as necessary
  • Serves as the QA Governance representative for Strategy Partners
  • Serves as the Subject Matter Expert on QA Quality Management Documents (QMDs)
  • Conducts employee performance appraisals as per Worldwide processes
  • Provides leadership oversight, supervision, mentorship, and coaching to employees
  • Performs other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

 
SKILLS AND ABILITIES:

  • Demonstrated advanced organizational leadership competencies
  • Demonstrated ability for driving results and role modeling a cross-functional collaborator
  • Demonstrated ability to effectively communicate, escalate, and influence the outcomes of the decision-making process
  • Demonstrated advanced project management and decision-making skills
  • Demonstrated advanced ability to effectively communicate and influence the outcomes of the decision-making process
  • Communicates professionally, concisely, clearly and consistently to external and internal customers both verbally and in writing
  • Demonstrated ability to think critically and lead calmly in complex situations, with strong decision-making skillset
  • Acts without authority to drive performance and accountability
  • Ability to lead a team of individuals with a clear vision and defined purpose
  • Demonstrated skills for influencing, being resourceful, managing conflict and negotiating
  • Demonstrates an advanced aptitude for facilitating group or project initiatives and building team unity
  • Works with a sense of urgency; ability to recognize time sensitivity and leads assertively
  • Has a strong understanding of clinical research principles and processes for clinical trials
  • Demonstrated advanced ability to implemented risk management strategies
  • Demonstrated ability to implemented risk management strategies and participates in protocol risk assessments as necessary
  • Previous experience with leading/participating in FDA BIMO inspections, MHRA GCP inspections, Health Canada GCP inspections, EMA GCP inspections, and other international Regulatory inspections is an asset

 
REQUIREMENTS: