Inotiv · 2 weeks ago
Associate Director, Quality Assurance North America Operations
Greater Indianapolis
Full-time
Hybrid
Lead/Staff, Director/Executive
$102K/yr - $130K/yr
5+ years expInotiv is a growing contemporary drug discovery and development company, and they are seeking an Associate Director of Quality Assurance to lead a team across North America. This role is responsible for ensuring compliance with regulatory standards, driving consistency in quality processes, and leading continuous improvement initiatives.
BiopharmaLife ScienceMedical DevicePharmaceutical
Hiring Manager
Julie Melton, EdD
Responsibilities
Leads a team of Quality Assurance Managers across North America in ensuring compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and CDC
Provides guidance, support, mentoring, and training to Regional Quality Assurance Managers across multiple sites
Ensures consistency and standardization of quality processes across all sites
Conducts regular site visits to monitor and assess quality performance
Applies rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectations
Analyses trend data to identify key areas of opportunities that impact product quality
Tracks and trends performance of quality systems and prepares and presents status reports for key performance indicators to management
Leads and participates in Continuous Improvement projects
Leads and participates in project teams to implement Quality Management Systems elements including, but not limited to, Deviation Management, Document Control and Change Control
Collaborating cross-functionally to ensure thorough, accurate and timely responses to customer audits and surveys
Ensures timely and effective communication with customers regarding quality issues
Performs other duties as assigned
Qualification
Required
Bachelor's degree in relevant field
5+ years' experience in Quality Assurance leadership
Six Sigma Black Belt
Proficient with advanced skills using Microsoft Excel, Word and PowerPoint
Experience with laboratory animals, especially rodents
Working knowledge of business-related processes/procedures terminology and compliance
Experience using Laboratory Information Management System
Ability to work either independently or as part of a team
Demonstrable leadership capabilities with the Ability to develop and foster a positive and productive team environment
Constructive and approachable
An individual who possesses initiative, drive, and flexibility with the ability to meet established timelines
Analytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutions
Understand business needs from multiple points of view and provides suggestions to address current issues while also maintaining a long-term solution
Excellent verbal and written communication skills; must be able to relate complex concepts in a concise and easy to understand manner with high attention to detail
Ability to prioritize and handle multiple demands, often under tight time constraints
An individual capable of operating effectively in a fast paced, dynamic environment
Adherence to strict quality control and quality assurance principles
Strong interpersonal/relationship-building skills that establish trust, credibility and respect with a broad range of internal and external stakeholders, including management
Effectively work with peers, leadership, and stakeholders in a productive collaborative environment
Strong commercial skills
Ability to understand and comply with confidentiality and privacy rules and protect company property and confidential information
Empathetic, positive attitude with a desire to help our customers reach their goals
Regular business travel is required
Up to 40% travel required
Benefits
Health and dental coverage
Short- and long-term disability
Paid time off
Paid parental leave
401K
And more!
Company
Inotiv
Inotiv provides biopharmaceutical analytical, reproductive toxicology, medical device testing, DMPK, consulting and pathological services.
1001-5000 employees
H1B Sponsorship
Inotiv has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (2)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$27.64MKey Investors
Indiana Economic Development Corporation
2024-12-18Post Ipo Equity· $27.6M
2022-06-20Grant· $0.04M
1997-11-28IPO
Leadership Team
Greg Beattie
Chief Operating Officer
Recent News
2025-12-13
2025-12-11
Company data provided by crunchbase