Associate QA Director

IQVIA


Job Location:

Durham, NC - USA

Monthly Salary: $ 88600 - 246600
Posted on: 3 hours ago
Vacancies: 1 Vacancy

Job Summary

Job Overview
Provide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes. 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
Bachelors Degree Pref
10 years experience Quality Assurance experience in pharmaceutical technical or related area including GXP Quality Assurance experience. Equivalent combination of education training and experience.
Knowledge of word-processing spreadsheet and database applications.
Strong knowledge of pharmaceutical research and development processes and regulatory environments.
Considerable knowledge of quality assurance processes and procedures.
Strong interpersonal skills and the ability to positively influence and guide others.
Excellent problem solving risk analysis and negotiation skills.
Effective organization communication and team orientation and leadership skills.
Possess applicable experience in conducting audits writing audit reports and analyzing audits.
Demonstrated ability to lead and manage multiple responsibilities.
Identify functional constraints and identify solutions.
Ability to coordinate timelines with internal customers and external vendors.
Ability to manage multiple activities and timelines.
Ability to articulate and define departmental needs and processes.
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 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. 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 $88600.00 - $246600.00. 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.

Required Experience:

Director

Job OverviewProvide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes. Oversee & coordinate assigned QA program in support of customer accounts functional accounts audit and inspection program or QA quality management sys...

About Company

Company Logo

IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more

View Profile View Profile