Associate Director Quality Management

IQVIA; Madrid; On-site; EUR 90,000 - 130,000; Full time

Job summary

IQVIA in Madrid is seeking a CQM Lead to drive quality management initiatives across clinical programmes. The role focuses on implementing risk-based quality controls and providing strategic guidance on GCP compliance.

Requires a minimum of 12 years in clinical trial processes, advanced degrees, and fluent English. Travel within the region may be required. Leadership responsibilities include directing teams and collaborating with cross-functional stakeholders.

Qualifications

• Minimum 12 years in processes related to clinical trial design, planning, start up, conduct, analysis, and reporting.
• Knowledge of ICH, GCP, SOPs and regulatory requirements.
• Excellent organizational, interpersonal and communication skills.

Responsibilities

• Leads quality management initiatives and risk-based approaches across assigned units.
• Advises stakeholders on quality control, risk assessment, and corrective/preventive actions.
• Plans and implements Quality Management activities and reports.
• Supports audits and regulatory inspections as required.

Education

Bachelor's or Master's in Medical/Life Science

PhD preferred

Tools

Microsoft Office

Job description

Job Overview

This role is assigned to designated Delivery Unit(s), country/countries, sponsor(s), business units(s), and/or specific tasks as defined by the line manager (LM). Contributes to the development and is responsible for the implementation of specific quality improvement initiatives as agreed with the relevant Head(s) of assigned business lines. Provides advice and supports relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.

Essential Functions

• The CQM Lead leverages expertise in risk-based quality and study management to drive actions that strengthen & standardize risk-based approach &deliverables via fit-for-purpose business processes/tools.
• Contributes to the development, and supports implementation of the 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 in project delivery.;
• Cooperate closely with the relevant business lines and other stakeholders, support maintaining focus on quality in project delivery.
• Provides advice and support to teams within the assigned business line on all aspects of Good Clinical Practice (GCP) compliance.
• Works in close cooperation with teams to manage non-compliance, quality issues
• Assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).
• Informs the assigned business line and Quality Assurance of quality issues according to SOPs.
• Works 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 line manager, as required by the applicable SOPs.
• Acts as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
• Prepares periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.
• Manages 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.;
• Upon agreement with the Head of relevant business line: Performs any other reasonable tasks as required by the role.

Qualifications

• Bachelor’s or Master's degree in Medical or Life Science (or equivalent industry experience) required, and PhD preferred.

Expert knowledge of and experience in (minimum of 12 years) processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principles and concepts as well as regulatory environment).

• Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.
• Excellent organizational, interpersonal and communication skills.
• Excellent judgement and decision-making skills.
• Demonstrated leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem-solving skills.
• Demonstrated ability to work in a matrix environment.
• Ability to lead and motivate a clinical team also required.
• Ability to travel within the region/country.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• 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. 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.