Associate Director, Quality Audit & Compliance

Inotiv; Indianapolis (IN); Remote; USD 101,000 - 130,000; Full time

Job summary

An established industry player is seeking an Associate Director to enhance its global compliance program. This pivotal role involves conducting risk assessments, executing audits, and fostering a collaborative environment between the company and its stakeholders. With a focus on quality management and continuous improvement, the position offers a chance to make a significant impact on the organization’s growth and compliance standards. Join a dynamic team dedicated to advancing drug discovery and development solutions that improve lives worldwide. If you are driven by excellence and possess strong leadership skills, this opportunity is tailored for you.

Benefits

Health and dental coverage

Short- and long-term disability

Paid time off

Paid parental leave

401K

Flexible working hours

Professional development opportunities

Employee assistance program

Remote work options

Wellness programs

Qualifications

• 5+ years of experience in Quality Management Systems and Audit Programs.
• Proficient with advanced skills in Microsoft Office Suite.

Responsibilities

• Conduct risk assessments and evaluate internal controls.
• Oversee the development and execution of audit programs.

Skills

Quality Management Systems

Audit Programs

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Analytical Thinking

Leadership

Communication Skills

Interpersonal Skills

Problem Solving

Education

Bachelor's degree in Life Sciences

Tools

Laboratory Information Management System

Job description

The Associate Director is integral to the company's global compliance program by conducting risk assessments, evaluating internal controls, and executing customer, operational and compliance audits.

This position oversees the development, planning, and execution of internal and critical supplier audits and advisory projects; participate heavily in compliance activities; assess control deficiencies, monitor remediation efforts, and support the department's quality assurance and improvement initiatives. This role strives to create a positive and mutually beneficial relationship between Inotiv, its employees and its customers, contributing to achieving the growth of Inotiv RMS business. The salary range for this role is $101,800 - $130,000 and can adjust along with the level of the role to match the person's relevant experience and/or education level.

• Understands the organization's regulatory framework (USDA, AAALAC, IACUC, Home Office, Dutch regulatory framework, GLP, etc.)
• Develops and implements global audit program strategies and annual schedules relevant to risk and audit objectives
• Utilizes industry standard quality management tools (risk assessment, nonconformance reports, root cause analysis, corrective and preventive action management) within the audit program
• Guides and trains colleagues to create awareness and understanding of the audit program
• Verifies the implementation and effectiveness of the audit program through testing and interacting with relevant stakeholders
• Evaluates corrective and preventive action responses to audit or assessment findings for adequacy, including root cause and timeliness
• Provides leadership and guidance to cross-functional managers to deliver site-specific improvements and standards
• Works closely with the Associate Director, Quality and Regulatory Compliance in overseeing internal and customer audit observations and assessment activities relative to legal and regulatory risk areas specific to the division the role supports
• Analyzes, evaluates, and plans methods for the solution and continuous improvement of the quality management system (QMS), based on key learnings from internal and external audits, including follow up on observations and respective actions, and maintenance of audit documentation
• Generates, reviews and evaluates audit reports and audit report responses.
• Participates in the selection, evaluation, monitoring and development of critical suppliers
• Prepares and presents monthly and annual key performance indicators (KPIs)
• Prepares sites for regulatory inspections
• Regular business travel is required
• Performs other duties as assigned

Minimum Requirements

• Education: Bachelor's degree in the life sciences. Equivalent professional experience in Quality Assurance, Quality Control, Auditing may be considered in lieu of a degree.
• 5+ years' experience in Quality Management Systems and Audit Programs
• Proficient with advanced skills using Microsoft Excel, Word and PowerPoint
• Experience with laboratory animals, especially rodents
• Working knowledge of business-related processes/procedures terminology and compliance
• Experience using Laboratory Information Management System
• 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

#LI-JM1

#LI-Remote

*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.