Senior Wfm Manager: Forecasting, Scheduling & Real-Time

Anonymous; Cape Town; Hybrid; ZAR 1,994,000 - 2,991,000; Full time

Job summary

Anonymous seeks an Assoc Director, Quality Lead to oversee quality management for Data Management in a global FSP context. The role drives incident ownership, CAPA implementation, and portfolio-level QA activities across multiple regions.

You will coordinate investigations, supervise SMEs, and ensure TMF compliance and audit readiness while maintaining stakeholder relationships at senior levels.

Qualifications

• Bachelor's Degree or educational equivalence in clinical, biological or mathematical sciences or related field.
• 10 years of relevant work experience with substantial people management.

Responsibilities

• Act as primary quality incident owner across IQVIA QMS and Customer Quality System.
• Coordinate targeted investigations and allocate resources to CAPA actions.
• direct functional leads and SMEs using root-cause methods (5 Whys) to define CAPA.
• Escalate to leadership when needed to secure timely root cause and CAPA.
• Monitor TMF compliance and support audit readiness across portfolio.

Skills

Leadership

Project management

Stakeholder management

Communication

Problem solving

Education

Bachelor's Degree or equivalent

Tools

Data Management systems

Job description

Assoc Director, Quality Lead, Data Management FSP

Dublin, Ireland
Centurion, South Africa
Reading, Berkshire, United Kingdom
Bloemfontein, South Africa
Bellville, South Africa
Full time
**Quality Lead Job Overview**
Lead Quality Management processes in a team of Data Management professionals to efficiently produce databases that meet customer requirements.
**Quality Lead Functions**

• Act as the primary issue owner and centralized manager for any quality incidents (QI) logged in the IQVIA Quality Management System or Customer Quality System across the Customer Data Management Functional Service Partnership (FSP).
• Coordinate targeted investigation for QIs; includes making targeted resource requests of the relevant Functional Leads to support the QI investigations
• Direct the appropriate functional lead member(s)/SMEs in the investigation, utilizing quality issue investigation principles e.g. 5 whys to ensure the team establish the correct root cause and effective CAPAs, bringing together all inputs and documenting the QI investigation summary and CAPA clearly
• Escalate to Leadership Team where the required support is not available from within the functions to establish the correct root cause and/or CAPA in a timely manner
• Conduct and track partnership level investigations, summarizing outputs in the Quality Management System and drive portfolio level CAPA implementation (with support from the Functional Lead from the relevant function)
• Review aggregated QI data and performs analysis and identification of trends at portfolio level and ensure that recurring findings/errors are communicated internally and to the Sponsor
• Provides updates on CAPA progress to Customer and share corrective/preventative actions for review and discussion where appropriate
• Negotiation with customer where different views exist on root cause and ownership of quality issues to ensure that IQVIA's position is explained clearly with rationale, escalating where appropriate
• Monitor Trial Master File (TMF) compliance across the portfolio supporting audit/inspection readiness to supplement functional accountability
• May conduct internal Data Management Quality Reviews, including eTMF Reviews, as part of the portfolio Quality Management Team in order to fulfil business unit, customer and regulatory authority requirements and expectations
• May monitor portfolio level customer Key Performance Indicators (KPIs) for quality to supplement functional leadership management and reporting of 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

Qualifications

• 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 including substantial people management experience; or equivalent combination of education, training and experience

Requirements

• 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.
• Demonstrated ownership, initiative, and a solutions-focused approach.
• Technical programming skills and experience producing Data Management deliverables.
• Ability to remain confident, diplomatic, and effective when managing challenging situations.
• High School Diploma or equivalent required.

No relocation opportunities provided

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