Regional Manager, Quality Assurance at Inotiv

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 AccountabilitiesLeads a Quality Assurance team to ensure compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and CDCProvides guidance, support, mentoring, and training to direct reportsPrepares and revises documents that support regulatory and statutory requirementsApplies rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectationsPrepares customer complaint metrics and KPIs, and analyses trendsFacilitates root cause analysis on significant customer complaints and/or complaint trendsAssesses nonconformance reports with regards to the level of risk to product qualityAnalyzes trend data to identify key areas of opportunities that impact product qualityTracks and trends performance of quality systems and prepares and presents status reports for key performance indicators to managementFacilitates and reviews customer correspondence associated with complaintsReviews and approves complaint investigations and associated RCAs and CAPAsLeads and participates in Continuous Improvement projectsLeads and participates in the Document Control processReviews 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 proceduresLeads and participates in customer, supplier, internal and regulatory auditsPerforms compliance audits against Standard Operating Procedure (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practicesCollaborates cross-functionally to address audit findings by established deadlinesConducts training for new hires as requiredPromotes and complies with quality assurance proceduresPromotes and complies with health and safety proceduresSix Sigma Green Belt is preferredRegular business travel is requiredPerforms other duties as assignedMinimum Requirements3+ year's experience in Quality Assurance leadershipProficient with advanced skills using Microsoft Excel, Word and PowerPointExperience with laboratory animals, especially rodents preferredWorking knowledge of business-related processes/procedures terminology and complianceExperience using Laboratory Information Management System preferredAbility to work either independently or as part of a teamDemonstrable leadership capabilities with the Ability to develop and foster a positive and productive team environmentConstructive and approachableAn individual who possesses initiative, drive, and flexibility with the ability to meet established timelinesAnalytical 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 detailAbility to prioritize and handle multiple demands, often under tight time constraintsAn individual capable of operating effectively in a fast paced, dynamic environmentAdherence to strict quality control and quality assurance principlesStrong interpersonal/relationship-building skills that establish trust, credibility and respect with a broad range of internal and external stakeholders, including managementEffectively work with peers, leadership, and stakeholders in a productive collaborative environment.Strong commercial skillsAbility 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 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.