Clinical FSP Quality Manager

Please note, this is a 12 months fixed-term contract with a possibility for extension.

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.

This role provides advice and supports clinical staff and other relevant key stakeholders with regard to quality control, risk management, and corrective/preventive actions.

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

• Bachelor's Degree Bachelor's Degree or equivalent qualification

• Ability to come to the sponsor office in Warsaw three times/week.

• At least 5 years of experience in the pharmaceutical industry, preferably in Development Operations/Quality Assurance.

• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.

• Good understanding of the drug development process and related GXP activities.

• Good understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring.

• Excellent organizational skills, verbal and written communication skills, ability to prioritize and handle multiple tasks, attention to detail.

• Good presentation skills, integrity and high ethical standard.

• Manages change with a positive approach for self, team, and the business.

• Sees change as an opportunity to improve performance and add value to the business.

• Excellent knowledge of spoken and written English.

• Good ability to learn and to adapt to work with IT systems and ability to travel nationally and internationally as required.

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 zł 151.200,00 - zł 659.300,00. 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.