Job Description

The Regional Manager, Quality Assurance is responsible for performing responsibilities as assigned to effectively support implementation of the Quality Management System at the two Alice, TX sites and the one Denver, PA site. 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 nonhuman primate operations in achieving compliance to quality and animal welfare requirements, company policies and procedures, as well as all applicable regulatory requirements. The Regional Manager is expected to work on site daily at the Alice, TX sites and travel to Denver, PA every four to six weeks.

Key Accountabilities

• Leads a Quality Assurance team to ensure compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and CDC
• Provides guidance, support, mentoring, and training to direct reports
• Prepares and revises documents that support regulatory and statutory requirements
• Applies rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectations
• Prepares customer complaint metrics and KPIs, and analyses trends
• Facilitates root cause analysis on significant customer complaints and/or complaint trends
• Assesses nonconformance reports with regards to the level of risk to product quality
• Analyzes 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
• Facilitates and reviews customer correspondence associated with complaints
• Reviews and approves complaint investigations and associated RCAs and CAPAs
• Leads and participates in Continuous Improvement projects
• Leads and participates in the Document Control process
• Reviews and approves changes to controlled documentation (policies, procedures, etc.)
• Leads and participates in project teams to implement Quality Management Systems elements including, but not limited to, Deviation Management, Document Control and Change Management related procedures
• Leads and participates in customer, supplier, internal and regulatory audits
• Performs compliance audits against Standard Operating Procedure (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practices
• Collaborates cross-functionally to address audit findings by established deadlines
• Conducts training for new hires as required
• Promotes and complies with quality assurance procedures
• Promotes and complies with health and safety procedures
• Six Sigma Green Belt is preferred
• Regular business travel is required
• Performs other duties as assigned

Minimum Requirements

• 3+ year’s experience in Quality Assurance leadership
• Proficient with advanced skills using Microsoft Excel, Word and PowerPoint
• Experience with laboratory animals, especially rodents preferred
• Working knowledge of business-related processes/procedures terminology and compliance
• Experience using Laboratory Information Management System preferred
• 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

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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.