Manager Quality Assurance, Bioanalysis
Share
Job Location:
Indianapolis, IN - USA
Monthly Salary:
$ 75400 - 188600
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a Manager Quality Assurance - Bioanalysis to join IQVIA Laboratories in Indianapolis Indiana.
We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose join us as we transform and accelerate research and development.
As a Manager Quality Assurance - Bioanalytics you will oversee and coordinate assigned QA programs in support of customer accounts functional accounts audit and inspection programs or QA quality management systems at a regional and/or global level. You will provide support to management with insights analyses and support in the assessment and promotion of compliance with regulations guidelines and operating procedures risk identification and mitigation quality process and productivity/efficiency improvement initiatives. You will also act as a line manager for one or more QA staff and oversee staff development and team deliverables.
What youll be doing:
Providing guidance interpretation support training and key input to development groups for consultation and interpretation of regulations guidelines corporate standards and policies.
Overseeing and participating in the documentation reporting and closure of compliance issues.
Organizing and delivering training to other IQVIA departments concerning the activities of Quality services results of activities quality initiatives GXP etc.
Ensuring the follow-up of major and critical audit findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.
Evaluating policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Serving as author of Quality Assurance Standard Operating Procedures (SOPs) as assigned.
Advising Quality Assurance management on system audit needs.
Ensuring the Quality Assurance database is maintained and up to date to reflect the status of audits being scheduled auditor assignment and audit reporting and/or follow-up status.
What we are looking for:
Bachelors Degree Preferred.
7 years of Quality Assurance experience in pharmaceutical technical or related areas including GCP Quality Assurance experience.
5 years of management experience.
Or other equivalent combination of education training and experience may be accepted in lieu of degree.
The knowledge skills and abilities needed for this role:
An excellent knowledge of current GXP regulations and guidelines and associated regulatory requirements.
Knowledge of word-processing spreadsheet and database applications.
Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
Considerable knowledge of quality assurance processes and procedures.
What we offer you:
We put our employees at the center of everything we do and are committed to providing them and their families with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees physical mental emotional financial and social well-being so they can thrive at home and at work at any stage of their well-being journey.
To learn more about our benefits visit youre looking to unleash your potential join IQVIA Laboratories to help make the extraordinary possible!
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 $75400.00 - $188600.00. 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:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
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
