Manager, Quality Assurance

Qualifications:

• BS or BA degree in Biology, Chemistry or other relevant degree.
• At least 5 years experience in the CRO industry and 3 years supervisory experience or equivalent experience.
• Detailed knowledge of GLP's and regulatory agency guidelines (e.g. FDA, EPA)
• Excellent written and oral communication skills.
• Proficiency in basic computer applications such as MS Word, Excel, SharePoint, MasterControl.
• Strong attention to detail.

Corporate Responsibilities:

• Adherence to federal and/or local regulations as applicable
• Adherence to applicable company policies and guidelines
• Adherence to laboratory health and safety procedures
• Adherence to company Standard Operating Procedures (SOPs)

Position Responsibilities:

• Responsible for the effective operation of Quality Assurance (QA) team for one or more sites including supervision of all QA staff and their growth and development.
• Responsible for recruitment and performance management of direct reports.
• Responsible for generation of and adherence to financial budget.
• Provides tactical and strategic planning and coordinates with other sites in support of company initiatives.
• Oversees planning, scheduling, and resource allocation to enable effective operation of the QA team.
• Monitors and tracks completion of internal and external inspection and audit commitments.
• Provides management with a risk-based audit plan for process-based and facility audits, and ensures adherence to the plan.

• Ensures proper qualification of GxP subcontractors, vendors and suppliers via vendor management program.
• Provides QA support for equipment qualification and computer validation activities, as needed.
• Partners with operational and scientific leadership to support key initiatives and provide education and support on regulatory, quality and compliance topics.
• Resolves problems and collaborates with other department directors and staff for complex issues or when resolution requires input and support from other groups.

• Mentors and coaches staff as required to ensure continued growth, development and attainment of professional goals of team members.

• Hosts and/or participates in client and regulatory agency inspections and audits, as required.
• Monitors quality performance metrics for evaluation and trending of key measures.
• Delivers a periodic report to management summarizing performance metrics and detailing quality issues including trending and recommendation for remediation.

Additional Requirements:

• Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines.
• Proficient in time management and resource planning.
• Ability to perform duties with minimal supervision.
• Ability to initiate and implement self-development efforts.
• Advanced ability to effectively interact with clients and regulatory personnel.
• Ability to travel to international locations (25% to 30%)
• Overtime, weekend, and holiday work as required

This position is a salary position paying $92,200 to $120,00.00 USD. Please note that salaries vary within the range based on factors including experience, skills, education, certifications, and location.

*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.