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 initiatives. Manage 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 plans,as 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 and GXP 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 https://jobs.iqvia.com.
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.
