Clinical FSP Quality Manager

IQVIA•Durham, NC

2d•Hybrid

About The Position

The Clinical FSP Quality Manager is an individual contributor assigned to designated Delivery Units, sponsors, business lines, and/or tasks defined by the line manager. The role works with global or regional Quality Management teams, functional teams, and other stakeholders to define and implement a global Quality Plan tailored to the assignment. It supports staff in improving compliance with ICH, GCP, SOPs, KPIs, applicable regulatory requirements, and guidelines. The position adopts and implements quality and risk management plans, monitors their delivery, advises teams on GCP compliance, and supports the handling of non-compliance and quality issues. It works with Quality Assurance and business staff on suspected misconduct, may support audits and regulatory inspections, and serves as the primary Quality Assurance contact for quality matters within the assignment. The role also prepares periodic reports on quality matters, risk assessments, and improvement initiatives. This is a hybrid position requiring attendance at the Brussels office 2–3 times per week.

Requirements

At least 3 years of experience in a clinical quality or GCP compliance role.
At least 5 years of experience in medical device, clinical research, or a related industry.
Strong understanding of ICH GCP and knowledge of ISO 14155.
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 or customers.
Fluency in English.
Ability to work in a hybrid arrangement and attend the Brussels office 2–3 times per week.

Nice To Haves

GCP audit experience is strongly preferred.

Responsibilities

Adopt and implement the global Quality Management Plan within the assignment, including planning and executing quality management activities.
Identify and assess risks through data review and quality control processes; support risk mitigation, corrective and preventive action planning, and improvement guidance.
Support assigned business line management and staff in enhancing effectiveness and maintaining quality in project delivery.
Work with relevant business and other stakeholders to maintain focus on quality in project delivery.
Contribute to the development and implementation of Delivery Unit- or sponsor-specific Quality Management Plans and Risk Management Programs, and monitor their implementation and delivery.
Advise and support teams and key stakeholders on Good Clinical Practice (GCP) compliance.
Work with teams to manage non-compliance and quality issues and support corrective and preventive action planning in accordance with SOPs.
Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
Work with Quality Assurance and assigned business staff in cases of suspected misconduct, as required by applicable SOPs.
Assist teams during audits and regulatory inspections to the extent agreed with the business lines and required by applicable SOPs.
Act as the primary contact for Quality Assurance on assignment-level quality matters and attend meetings or teleconferences.
Prepare periodic business-line reports on quality matters, risk assessments, and quality improvement initiatives.
Perform other reasonable tasks as required by the role, upon agreement with the line manager.