Assoc Director, Quality Assurance, Customer Support Services

Job Overview

Provide insight which is exercisable across the large part of the organization. Oversee & coordinate assigned QA program in support of customer accounts functional accounts audit and inspection program or QA quality management system at a regional and/or global level. Provide insights analyses and support in the assessment and promotion of compliance with regulations guidelines and operating procedures risk identification and mitigation quality process productivity/efficiency improvement the quality assurance oversight of projects assignments training and staff.

Essential Functions
Plan schedule conduct report and close audit activities as assigned
Provide Quality Assurance support guidance and management of Quality Issues as assigned
Assist in the enhancement of Quality Assurance and control policy and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management
Serve as an author for QA Standard Operating Procedures (SOPs) and act as regional QA representative to the global QA SOP taskforce
Provide guidance interpretation support training and key input to development groups for consultation and interpretation of regulations guidelines corporate standards and policies
Host customer audits and participate in review of corrective action plansas assigned
Recommend systems for audit write systems audit plans coordinate scheduling conduct reporting and closure of internal system audits
Serve as the QA Contact for assigned internal/external customers and IQVIA functional areas
Oversee documentation reporting and closure of compliance issues
Support Quality Management in proposal reviews and reporting QA metrics
Conduct trend analysis of audit results provide to internal/external stakeholders as agreed as assigned
Oversee proper coordination of customer-initiated audits and mock regulatory inspections manage regulatory facility inspections as assigned
Participate in or lead (cross functional) teams for special projects as assigned
Promote the concept of quality the principles of quality management and devise and implement quality improvements

Qualifications
10 years experience Quality Assurance experience in pharmaceutical CRO andGXP Quality Assurance experience.

GCP QA experience is a big advantage.
Strong knowledge of pharmaceutical research and development processes and regulatory environments.

Knowledge of MHRA and FDA regulations is a must.
Considerable knowledge of quality assurance processes and procedures.
Excellent problem solving risk analysis and negotiation skills.
Possess applicable experience in conducting audits writing audit reports and analyzing audits.

Experience in a customer facing role is a big advantage.
Demonstrated ability to lead and manage multiple responsibilities.
Ability to coordinate timelines with internal customers and external vendors.
Ability to manage multiple activities and timelines.
Ability to establish and maintain effective working relationships with coworkers managers and clients.

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 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.

At IQVIA we believe that diversity inclusion and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone everywhere. When our talented employees bring their authentic selves and their diverse experiences to work they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise as part of this culture IQVIA is committed to ensuring effective equality between women and men integrating it as a strategic principle in its corporate and human resources policies.