IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
QUALITY MANAGER (Real World & Analytics Solutions)
The mission of the Quality Management team is to embed quality in everyday work. The job holder is assigned to quality initiatives and Quality Management responsibilities as well as specific tasks as defined by the QM's Line Manager (LM). The purpose of the job is to implement the mission and vision of Quality Management by implementing the Quality Management Plan according to the specific needs defined by the scope of assignment. The person in this position will assist the Real-World business line staff in improving compliance with relevant sections of GxP including ICH-GCP, SOPs, applicable regulatory requirements and guidelines. They will contribute to the development and be responsible for the implementation of specific quality improvement initiatives as agreed with the Head of Quality Management and the relevant Heads of business lines and functional departments. They will provide advice and support to relevant key stakeholders with regards to quality issues, quality control, risk assessment, risk management and corrective/preventive actions.
- Adopt and implement the Global Quality Management Plan within the scope of the assignment; this will include:
- planning and executing the Quality Management activities;
- risk identification and evaluation through quality assessments either remote or on site;
- providing support in risk mitigation, in planning corrective/preventive actions and guidance for improvement;
- supporting the RWAS line management and staff to enhance effectiveness of procedures and quality practices.
- Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of project- or Sponsor-specific Quality Management s and Risk Management Programs; monitor the implementation and delivery.
- Provide advice and support to operational teams and functional departments including key stakeholders on GxP compliance.
- Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.
- Inform Heads of Quality Management, Heads of the assigned business line and Quality Assurance of quality issues according to SOPs.
- Provide assistance to the operational teams in preparing for, and potentially during, audits and regulatory inspections.
- Coordinate with Quality Assurance on clinical quality matters as needed.
- Prepare periodic reports to various levels of the organization on quality related matters, risk assessments and specific quality improvement initiatives.
- Upon agreement with the Head of Quality/Operational Management:
- May serve as Line Manager of Quality Specialist (QS), Sr QS and/or QM
- May serve as Lead QM for a project or program
- Perform any other reasonable tasks as required by the role.
- If job holder is delegated as Line Manager:
- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), ICH-GCP, applicable regulatory requirements, quality management processes
- Knowledge of National and International Regulations and Drug Development processes
- Knowledge of CRO or Pharmaceutical industry operations
- Good organizational, interpersonal and communication skills
- Good judgement and decision-making skills
- Strong influencing and negotiation skills
- Strong computer skills including Microsoft Office
- Demonstrated ability to work in a matrix environment
- Excellent problem-solving skills
- Ability to travel within the region/country if needed
- Ability to lead and motivate a project or functional team
- Ability to establish and maintain effective working relationships with co-workers, managers and supported team members
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in life sciences or equivalent nursing qualification, or equivalent industry experience with a minimum of 4 years' experience in a pharma or clinical-related environment; or equivalent combination of education, training and experience.
- Fluent in English.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
Job ID: R1068447