FSP Associate Director - Quality Management

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

• 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).  
• At least 5 years of extensive working experience in Good Clinical Practice (GCP) in a must.

• Extensive experience working with Quality Management Systems is a must.

• 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. Learn more at 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.

The potential base pay range for this role, when annualized, is € 44.200,00 - € 94.100,00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.