Description
We are seeking a Quality Lead to manage quality management processes in a team of Data Management professionals. The successful candidate will be responsible for ensuring that databases produced meet customer requirements.
Key Responsibilities:
- Act as primary issue owner and centralized manager for quality incidents logged in the IQVIA Quality Management System or Customer Quality System
- Coordinate targeted investigations for quality incidents and make resource requests to support investigations
- Direct functional lead members in investigation, utilizing quality issue investigation principles to establish root cause and effective CAPAs
- Escalate to Leadership Team where required support is not available
- Conduct and track partnership level investigations and summarize outputs in the Quality Management System
- Review aggregated quality incident data and perform analysis to identify trends at portfolio level
- Provide updates on CAPA progress to Customer and share corrective/preventative actions for review and discussion
- Negotiate with customer where different views exist on root cause and ownership of quality issues
- Monitor Trial Master File (TMF) compliance across the portfolio
- May conduct internal Data Management Quality Reviews and monitor portfolio level customer Key Performance Indicators (KPIs) for quality
- Provide leadership and innovative ideas to the portfolio from a quality incident perspective
- Serve as Subject Matter Expert, providing quality incident and process improvement expertise to CDM management
- Maintain working knowledge of current applicable regulatory and Sponsor guidelines and related review techniques
Requirements:
- Bachelor's Degree or educational equivalence in clinical, biological or mathematical sciences or related field, or nursing qualification with 10 years of relevant work experience
- Advanced knowledge of Data Management processes, systems, and clinical drug development
- Strong leadership, staff management, and team development skills
- Proven project management experience with the ability to manage multiple priorities
- Solid financial management, budgeting, and business acumen
- Excellent communication, presentation, negotiation, and stakeholder management skills
- Strong problem-solving, decision-making, and organizational abilities
- Experience building and maintaining client and customer relationships at a senior level
- Ability to work effectively in a matrix environment and deliver results through collaboration and influence