RBQM Change Management Education Lead

Job Overview:

As a Risk Based Quality Management (RBQM) Change Management and Education lead you will be 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:

• Developing change management strategies: Creating a comprehensive plan to manage the adoption of RBQM processes including communication strategies training programs and stakeholder engagement initiatives.
• Designing and delivering training programs: Developing educational materials and workshops to educate employees about the changes addressing concerns and providing necessary skills to effectively utilize new systems.
• Communicating change effectively: Clearly communicating the rationale behind the change its impact and key timelines to all levels of the organization through various channels.
• Issue Management: Solicits and receives escalation of issues related to Study Teams experience of implementation of RBQM by Clinical Research Organization (CRO) and develops strategies and processes to resolve issues. As the organization adopts inhouse RBQM services provides DOQ consultation to support teams in managing issues related to RBQM implementation focusing on education and continuous improvement.
• Stakeholder management: Identifying key stakeholders managing their expectations and addressing any resistance to change.
• Monitoring and evaluation: Benchmarking baselining analyzing and tracking the progress of change implementation identifying areas for improvement and adjusting strategies as needed.
• 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 noncompliance 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 organizations 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:

• Masters degree or equivalent with a strong emphasis on business administration organizational development or datascience. Consideration will be given to individuals with other educational achievements with a strong overall profile.
• Minimum of 5 years experience in a pharmaceutical biopharmaceutical or Contract Research Organization company or equivalent.
• Minimum of 5 years experience in a role exposed to RBQM or minimum of 2 years experience in a lead role within RBQM.
• Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.
• 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 decisionmaking skills.
• Demonstrated leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills including Microsoft Office applications.
• Excellent problemsolving 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 coworkers 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

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. potential base pay range for this role when annualized is $117600.00 $218400.00. The actual base pay offered may vary based on a number of factors including jobrelated qualifications such as knowledge skills education and experience; location; and/or schedule (full or parttime). 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.