Reading books
Jelena Jovanović
Quality Management Professional
Novi Sad
Summary
Accomplished and quality-focused professional with 20+ years of experience working in a wide variety of different functional areas within pharmaceutical and fast-paced CRO industries. Proven track record of excellence managing underperforming business units and global projects/initiatives in both GCP and GMP environments. Demonstrated success in regulatory consulting, compliance strategies, process improvement, quality agreements, and regulatory audits. An articulate and refined communicator with native Serbian speakers, fluency over English, and basic knack over German languages.
Overview
21
21
years of professional experience
3
3
Languages
Work History
Director Quality Assurance
IQVIA RDS
11.2024 - Current
- In my current role as a Strategic Quality Lead, I am responsible for managing Key Customer Account(s) for IQVIA, including different business lines, globally representing IQVIA QA by establishing and maintaining relationships with QA functions of assigned Key Customer
- This includes provision of QA strategy for the Customer accounts managed, oversight and/or delivery of services such as routine, directed or for cause audits of projects, procedures or systems, provision of consultancy services, provision of data on quality of IQVIA' work derived from Global QA systems, oversight of investigations of quality issues and oversight of customer audits and regulatory inspections related to assigned Key Customer(s)
- All activities are to be delivered in a way that independently assures the compliance and quality of processes, systems, and projects whilst inspiring and facilitating continuous improvement
Director Quality Management
IQVIA RDS
04.2022 - 10.2024
- Cross functional, key, strategic, relationship quality hybrid 'Quality Indication Lead' role, working in a special set up with a high-profile Customer
- Responsibilities includes developing/evolving the quality strategy and Quality Management System (QMS), Framework as well as delivery of services such as risk identification and management on a project/program level; Inspections and audits and Quality Issues management, including CAPA; audit program development; monitoring of compliance within the clinical delivery processes aligned with the global QMS Framework; evaluation of the impact made by the quality management activities; inspection readiness activities; provision of data on quality and driving initiatives
- Designing and implementing a unique, hybrid quality role (QM/QA) per the Customer expectations in the specific set up with a goal of a proactive engagement and delivery
- QMS Framework implementation to allow timely oversight of the account level, projects/programs health and include a proactive risk assessment and management model
Associate Director Quality Assurance
IQVIA RDS
04.2020 - 04.2022
- Collaborate with the quality assurance leadership team and other company's departments, including legal, internal audit and inspection strategy, human resources, operations, safety, and security, focusing on critical quality deliverables, including metrics defining, reporting, and process improvements
- Administer fully outsourced, GFR (partial outsource) and Real-World trials globally as per customer portfolio
- Tactfully negotiate, secure, and execute quality management agreements (QMA), while ensuring compliance and quality of processes, systems, and projects
- Engage with key stakeholder and support departments on quality issues CAPAs
- Hosting and managing audits (system/process/qualification audits), including FDA/EMA/MHRA, and other health authority inspections
- Line managing staff within the QA Customer Strategic Team (CST)
- Successfully aligning the quality strategy and framework including re-negotiation of a QMA on an account level with the Customer counterpart as solely responsible QA representative
- Driving the setup, preparation and risk assessment, including hosting and CAPA management of series of inspections (site level, CRO, Customer) on a specific Customer program that has an impact on the marketing authorisation in near future
- Strategically setting up and delivering inspection readiness strategies on Customer-CRO interface global and local (Japan, China) level with purpose of BLA/MAA/JNDA/NMPA/MFDS application and post file submission Inspection management toward granting Marketing authorisation
Quality Assurance Manager
IQVIA RDS
11.2015 - 04.2020
- Successfully managed a number of inspection readiness processes on customer programmes, including post file submission Inspection management, which resulted in relevant EMA and FDA Marketing approvals
- Developed and implemented inspection readiness strategies on Customer-CRO interface level with purpose of BLA/MAA/JNDA application
- Led the management of identifying critical (and major) items and serious breaches through quality issue management, audit, and inspection process
Quality Management Manager
IQVIA RDS
02.2011 - 11.2015
- Assumed accountability for delivering key strategic quality oversight to manage key customer accounts globally
- Conducted analysis of key quality indicators (KQIs) to identify root cause solutions for continuous improvements
- Established and strengthened key quality business relationships with strategic customer accounts
- Implemented and delivered quality management plan in line with Customer GFR model level, while identifying risk factors and monitoring compliance strategy
- Oversaw and supervised SOP task force activities and ensured quality assurance procedures and processes correctly employed within the unit
- Spearheaded the successful execution and global rolled out of the site inspection readiness (SIR) system (Apex and Spotfire) and process within the customer account, enhancing the quality oversight of the GFR customer model and quality management on projects, sites, and CRAs
- Drove the business transition process from Customer to CRO and implementation of customer GFR accounts in 80+ countries
- Implemented quality assessment visits that improved quality metrics to zero critical direct findings
Quality Assurance Manager
Accelsiors CRO and Consultancy Service
09.2007 - 02.2011
- Built and administered a fully functional quality assurance unit, managed 3 people in the department, and liaised with quality assurance representatives/auditors and governmental inspections, ensuring effective communication between company's and parties for all matters related to company quality management system, GCP, and SOPs
- Provided training, advice, and support to all internal/external parties regarding quality assurance matters
- Evaluated company's quality manual and supported in the development of quality improvement plan for each company functional unit, achieving improvement targets and resolving compliance issues
- Optimised existing standards and procedures, including electronic record management system in line with local and international regulatory requirements
Senior Quality Assurance Associate
Hemofarm A.D. (Stada Group)
03.2004 - 09.2007
- Oversaw and facilitated the implementation and improvements of quality assurance processes through SOP management, change control, corrective and preventive action plans, deviation management, GMP trainings, and audits/inspections management
- Played a key role as validation team member by managing various projects within the pharma company with the purpose of FDA product certification preparation, including qualification project of injections plant and microbiological laboratory and execution of SAP business suite (SAP R/3 and SAP-BW) according to companies' needs in Serbia and Russia
- Supported on site FDA Certification Inspection (May 2007), resulting in achieving marketing approval
Education
Master's - Pharmacy
University of Belgrade - Faculty of Pharmacy
Skills
Strategic Planning & Execution
Awards
- LEAN certified internally at IQVIA
- GCP Accreditation - Barnett Accreditation
- Regularly attending Conferences from different Agencies.
- Member of RQA.
- Recognition Awards, including Customer Recognition Awards
Interests
Learning
Art
Hiking
Spending time with people
Traveling
Dancing
Timeline
Director Quality Assurance
IQVIA RDS
11.2024 - Current
Director Quality Management
IQVIA RDS
04.2022 - 10.2024
Associate Director Quality Assurance
IQVIA RDS
04.2020 - 04.2022
Quality Assurance Manager
IQVIA RDS
11.2015 - 04.2020
Quality Management Manager
IQVIA RDS
02.2011 - 11.2015
Quality Assurance Manager
Accelsiors CRO and Consultancy Service
09.2007 - 02.2011
Senior Quality Assurance Associate
Hemofarm A.D. (Stada Group)
03.2004 - 09.2007
Master's - Pharmacy
University of Belgrade - Faculty of Pharmacy
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