Clinical FSP Quality Manager

Regulatory Toolkit; Durham (NC); On-site; USD 63,000 - 216,000; Full time

Job summary

IQVIA seeks an experienced QA/Quality Lead to join our global quality management efforts for clinical trials. You will partner with delivery units, sponsors, and business lines to drive GCP compliance and risk mitigation, guiding staff and stakeholders in quality improvements.

With a minimum of eight years in clinical trial processes and knowledge of SOPs and regulatory standards (ICH/GCP), you will lead QA activities, audits, and corrective actions while collaborating across regions to ensure

Qualifications

• Minimum 8 years in clinical trial design, planning, startup, conduct, analysis, and reporting.
• Bachelor's Degree or equivalent.
• Knowledge of ICH, GCP, SOPs, and regulatory requirements.
• Knowledge of drug development and CRO/pharma industry operations.
• Strong organizational, interpersonal, and communication skills.
• Willingness to travel within the region/country and lead teams.

Responsibilities

• Adopt and implement the global Quality Management Plan within scope.
• Support quality management in project delivery with stakeholders.
• Develop and monitor a Delivery Unit Quality Plan and risk program.
• Provide guidance on GCP compliance and SOPs to teams.
• Prepare periodic quality reports for line management.

Skills

Clinical trial design

Regulatory knowledge

Communication skills

Leadership

Problem solving

Microsoft Office

IQVIA SOPs

CRO/pharma ops

Travel ability

Team motivation

Education

Bachelor's Degree

Job description

Job Profile Summary

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

• 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).
• Bachelor's Degree or equivalent qualification or equivalent combination of education, training, and experience.
• Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes.
• Knowledge of National and International Regulations and Drug Development processes.
• Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
• Knowledge of IQVIA corporate standards and SOPs.
• Good organizational, interpersonal and communication skills.
• Good judgement and decision-making skills.
• Strong influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problem solving skills.
• Ability to travel within the region/country.
• Ability to lead and motivate a clinical team.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

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 $62,800.00 - $216,000.00. 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.