Manager Quality Assurance, Bioanalysis

IQVIA • Indianapolis, IN

22h • $75,400 - $188,600

About The Position

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.

Requirements

• Bachelor's 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.
• 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.

Responsibilities

• 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.

Benefits

• 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 https://jobs.iqvia.com/benefits
• The potential base pay range for this role, when annualized, is $75,400.00 - $188,600.00.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager