Clinical FSP Quality Manager

Job summary

Implement and monitor quality management plans and risk programs for assigned business units, sponsors, and teams, supporting GCP compliance and quality improvement. Identify and manage quality risks and non-compliance, coordinate corrective and preventive actions, report quality issues, and support audits and regulatory inspections.

Job details

Job Overview This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines. Essential Functions • 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 assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.; • Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery. • Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery. • Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance. • Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.); Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.; • Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs. • Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs. • May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the business lines, as required by the applicable SOPs. • Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences. • Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives. • Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.; Qualifications • Expert knowledge of and experience in (minimum of 8 years) processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principles and concepts as well as regulatory environment). • Knowledge of National and International Regulations and Drug Development processes. • Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations. • Excellent problem solving skills. • Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers. • Fluent in English. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com [https://jobs.iqvia.com/] IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

What you’ll do

Implement and monitor quality management plans and risk programs for assigned business units, sponsors, and teams, supporting GCP compliance and quality improvement. Identify and manage quality risks and non-compliance, coordinate corrective and preventive actions, report quality issues, and support audits and regulatory inspections.

Requirements

Requires at least 3 years of experience in clinical quality or GCP compliance and at least 5 years in medical devices, clinical research, or a related industry, with strong knowledge of ICH GCP and ISO 14155. GCP audit experience is strongly preferred; candidates should also understand applicable regulations and drug development, have strong problem-solving and relationship-building skills, and be fluent in English.

Listed skills

• Problem solving · Preferred
• Regulatory Compliance · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Clinical Quality Management
• Good Clinical Practice (GCP)
• ICH GCP
• ISO 14155
• Quality Management Planning
• Risk Identification and Assessment
• Risk Mitigation
• Corrective and Preventive Actions
• Regulatory Compliance
• Quality Auditing
• Regulatory Inspections
• Non-Compliance Management
• Clinical Research
• Medical Devices
• Problem Solving
• Stakeholder Collaboration
• Quality Assurance
• Standard Operating Procedure
• Key Performance Indicators (KPIs)
• Planning
• Management
• Operations
• English Language
• Risk Management
• Honesty
• Innovation
• Pharmaceuticals
• Project Delivery
• Risk Analysis
• Professionalism
• Auditing
• Quality Management
• Quality Improvement
• Cooperation
• Life Sciences
• Population Health
• Quality Control Processes
• Healthcare Industry Knowledge
• Corrective And Preventive Action (CAPA)
• Good Clinical Practices (GCP)
• Commercialization
• Drug Development

Job areas

• Healthcare
• Management & Leadership
• Science & Research
• Clinical Quality Manager
• Health Service Managers
• Quality Control Systems Managers
• Industrial Production Managers

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