Regional Quality Assurance Manager

3 days ago

Indianapolis, United States Inotiv Full time
Regional Quality Assurance Manager Location : Location US-IN-Indianapolis ID 2024-4757 Category Operations Type Full Time - Permanent Overview

The Regional Manager, Quality Assurance is responsible for performing responsibilities as assigned to effectively support implementation of the Quality Management System at the Indianapolis, IN sites. The manager will provide quality oversight for customer complaint management, root cause analysis (RCA), corrective and preventive action (CAPA) management, and documentation. The manager will oversee processes, such as the external and internal audit program, deviation management, change control, electronic quality management systems, quality training, and data collection. The manager is required to support operations in achieving compliance to quality and animal health standards, company policies and procedures, as well as all applicable regulatory requirements. The Regional Manager is expected to work on site daily at the Indianapolis, IN sites.

Responsibilities
  • Managing programs to ensure compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and DEA
  • Preparing and revising documents that support regulatory and statutory requirements
  • Applying rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectations
  • Tracking and trending performance of quality systems (i.e., customer complaints) and preparing and presenting status reports for key performance indicators to management.
  • Facilitating root cause analysis on significant customer complaints and/or complaint trends
  • Assess nonconformance reports with regards to the level of risk to product quality
  • Analyse trend data to identify key areas of opportunities that impact product quality
  • Facilitating and reviewing customer correspondence associated with complaints
  • Reviewing and approving complaint investigations and associated RCAs and CAPAs
  • Leading and participating in Continuous Improvement projects
  • Participating in the Document Control process
  • Reviewing and approving changes to controlled documentation (policies, procedures, etc.)
  • Leading and participating in project teams to implement Quality Management Systems elements including, but not limited to, Deviation Management, Document Control and Change Management related procedures
  • Leading and participating in customer, supplier, internal and regulatory audits
  • Performing compliance audits against Standard Operating Procedure (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practices
  • Collaboratively working with Operations and other functional departments to address audit findings by established deadlines
  • Collaborating cross-functionally to ensure thorough, accurate and timely responses to customer audits and surveys
  • Conducting training for new hires as required
  • Promoting and complying with Envigo's quality assurance procedures
  • Promoting and complying with Envigo's health and safety procedures
  • Fulfilling any other assigned duties that may be required by Envigo
  • Managing direct reports
  • Perform other duties as assigned
Qualifications
  • B.S./B.A. required in technical degree; 3-5 years of experience working in Quality Assurance-related area required
  • Experience with Quality Management System software
  • Excellent Excel skills and/or other data analysis tools to create and analyse data (pivot tables, graphs)
  • Auditing experience
  • Experience with performing Root Cause Analysis and Change Control
  • Excellent computer skills including Word, Excel, Power Point and Visio
  • Excellent written and verbal communication skills
  • Excellent organizational skills, analytical abilities, and ability to multi-task
  • Ability to work collaboratively in a teamwork environment
  • Ability to be a self-starter and work independently
  • Fluent in English, spoken and in writing
  • Excellent interpersonal and customer service skills; builds rapport to influence message, acceptance and understanding
  • Excellent organizational skills and attention to detail
  • Actively seeks opportunity to develop own skills and knowledge
  • Gives practical support and assistance to enable individuals to get the job done
  • Discusses process improvement opportunities within own department and across other areas
  • Demonstrates effective use of time and resources
  • Routinely meets agreed deadlines
  • M-F onsite required and need to be available for emergency calls
  • Will be required to enter barriers with biosecurity

Preferred Skills/Abilities:

  • Experience in the life sciences related industry
  • Experience working around laboratory animal models
  • Experience in Good Laboratory Practices (GLP) and Good Clinical Practices (GCP)
  • Certified Quality Auditor (CQA)
  • Lean Six Sigma Quality-related certification
  • AALAS Certification
  • Experience with JD Edwards

*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.

Inotiv has been named a 2023 Top Workplace

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.

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