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Manager, Quality Management

Aplica ya
Mapa de ubicación: Durham, North Carolina, United States Full time R1169291

Descripción del trabajo

***This is a Remote position & the successful candidate must be able to travel domestically approximately 50% - 75% - initially due to a number of Site audits.

IQVIA is changing an entire industry through inspired innovation. Our People make the difference. We believe that great ideas can come from anywhere. Great products come from great ideas. And great ideas come from great people. We look for the very best people and then give them meaningful work to do. Join IQVIA and help us make the world a better place.

PURPOSE

The purpose of the Job is to work together with global Quality Management and other stakeholders in a joint effort to define and execute a Quality Plan for AVACARE sites. Will assist the clinical staff on improving compliance with relevant ICH-GCP, SOPs, applicable regulatory requirements and guidelines and will provide advice and support to AVACARE clinical staff and other relevant key stakeholders with regards to quality control, risk management and corrective/preventive actions.

RESPONSIBILITIES

• 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 and 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 and Site audits.

• 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.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's Degree Preferred

  • Typically requires 2 – 5 years of prior relevant experience.

  • Requires some project management experience over Site audits.

  • 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 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. Will handle Site-level Project Management needs – including audits, etc. 

  • Ability to establish and maintain effective working relationships with co-workers, managers and clients.

  • Fluent in English.

https://www.avacare.com/

#LI-GaleBurns

#LI-Remote

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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