Manager, Quality Assurance

Inotiv
parental leave, paid time off, 401(k)
United States, Indiana, West Lafayette
Feb 05, 2025
The Quality Assurance Manager, is responsible for the management of a Quality Assurance Program at their Inotiv site that encompasses the relevant aspects of appropriate federal regulations. The QA Manager is responsible for coordinating the compliance activities at their facility by working with QA management/staff, and other related functional team members to assure compliance. This position ensures that quality audit programs are in place to evaluate compliance with SOPs, protocols and relevant regulatory requirements. The QA Manager will supervise QA staff in the execution of the audit program and review process and will manage regulatory inspections and sponsor audits. The QA Manager may also be responsible for performing quality audits and process reviews. In addition, the Manager Quality Assurance will evaluate the significance of audit findings and coordinate responses with Inotiv's management as needed. Design, develop, implement and manage the QA program to ensure compliance with all relevant regulatory requirements included but not limited to GLPs. Ensure audit programs are in place to assess compliance with SOPs, protocols, and relevant national regulations. Ensure quality assurance monitoring of all regulated studies conducted in the facility and make recommendations to management to address deficiencies. Keep abreast of new rules, guidance and industry standards in order to improve laboratory compliance. Manage regulatory and sponsor audits; make recommendations to management to address deficiencies. Supervise and train QA staff to meet Quality Assurance goals. Implement corporate policies, provide discipline, conduct personnel reviews, recommend adjustment of salaries and facilitate professional working conditions. Provide regulatory training for all scientific staff members. Assign and monitor daily projects for the quality assurance group. Assure management that all work is conducted in accordance with Inotiv policies and procedures and applicable government regulations. Participate in in-house training programs for the technical staff. Maintain confidential information. Interact with the community and employees. Support and participate in other company initiatives as directed by senior management. Perform other duties as assigned. #LI-JM1 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.