Manager, Quality Assurance

6 days ago

West Lafayette, United States Inotiv Full time

Overview:

The Manager, Quality Assurance 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 Inotivs management as needed.

Responsibilities:
  • Design, develop, implement and manage the QA program to ensure compliance with all relevant regulatory requirements included but not limited to GLPs, particularly as applicable to medical device testing.
  • 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


Qualifications:

B.S/B. A in a science related field with at least 5 years of direct GLP quality assurance experience in the pharmaceutical, contract research or medical device industry. An advanced degree in science is highly desirable. Supervisory experience required. Relevant quality certifications preferred.

Skills and Abilities

Ability to use personal computers to write reports

Excellent written and verbal communication skills

Ability to comprehend and apply applicable government regulations

Ability to adhere to safety regulations and procedures

Ability to interact and problem solve with all quality assurance and scientific staff

*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 persons 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. Theres an opportunity for everyone at all phases of a career, each individuals unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of peoples 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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