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Associate Director, Quality Assurance North America Operations

2 weeks ago


Indianapolis, IN, United States Inotiv Full time

Responsible for leading a team of Quality Assurance Managers across North America to ensure compliance with regulatory standards (AAALAC, IACUC, USDA, CDC). This role drives consistency in quality processes, oversees audits, and leads continuous improvement initiatives. The position requires strong leadership, analytical skills, and the ability to collaborate cross-functionally to maintain high-quality standards and customer satisfaction.

Key Accountabilities

  • 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
  • Six Sigma black belt is preferred
  • Regular business travel is required
  • Performs other duties as assigned

Education:

  • Bachelor's degree in relevant field

Experience :

  • 5+ years' experience in Quality Assurance leadership
  • Or equivalent combination of education and experience

Certifications (Preferred but not required):

  • Six Sigma Black Belt

Travel:

  • Up to 40% travel required

Skills & Knowledge:

  • 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

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range for this role is $101,800 - $130,000 and can adjust along with the level of the role to match the person's relevant experience and/or education level.

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*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.