Job Type

Full-time
Description
ABOUT MEITHEAL PHARMACEUTICALS
Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectables and, as of 2022, has expanded its focus to include fertility, biologics, and biosimilars. Meitheal currently markets 50 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of April 2023, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 21 products planned for launch in 2023, and an additional 20 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked among the top 100 Crain's Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for - Meitheal (Mee•hall): working together toward a common goal, for the greater good.
The Quality Auditor position's primary responsibility is to manage and oversee the Supplier Quality management and the Audit Program. Schedule, plan, coordinate, and execute compliance audits of Meitheal's contract manufacturing partners, API vendors and other CGMP service providers. Meitheal's products includes generic injectables, biologics and biosimilars. Assess supplier's conformance with applicable US FDA CGMP regulations and industry standards. Conduct routine performance monitoring and risk assessment of supplier to report any non-conformances or performance issues. Conduct internal audit of Meitheal's quality systems for adherence to procedures and regulations and support management during external inspections. Assist in generating and maintaining Quality Agreements and support other QMS functions, as necessary.
Essential Duties and Responsibilities
1) Independently manage Supplier Quality management activities, including:
- Coordinate with suppliers to schedule and plan supplier audit activity.
- Ensure adherence to audit schedule.
- Prepare audit agenda and plan.
- Conduct supplier audit, generate audit report and report findings to partners and Meitheal management.
- Perform due diligence reviews and audit of potential new suppliers.
- Evaluate audit finding responses and CAPA from partners for adequacy, including root cause
determination and ensure timely closure of findings.
- Evaluate supplier's performance annually and report performance and compliance issues to Meitheal management.
- Manage and maintain the Approved Vendor list.
- Collect, trend and report supplier quality metrics.
2) Oversee the Internal Audit program including preparing audit agenda, conducting internal audits, writing audit reports, evaluating audit finding responses and tracking through to closure.
3) Support management during external inspections.
4) Assist in generating and maintaining Quality Agreements with suppliers.
5) Remains current in regulatory trends and requirements.
6) Willingness to travel domestically or internationally up to 25%-50%.
7) Provides support to other areas in quality department, including but not limited to, review of complaints and non-conformance investigations and supporting existing Meitheal QMS functions, as necessary.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's in science or equivalent degree. 5 -10 years of experience with Quality Management systems including audits with a pharmaceutical company.
• Background in production or testing in an aseptic processing facility is desirable.
• In-depth knowledge of FDA regulations and industry standards pertaining to manufacture of generics and/or biologics or biosimilars.
• Good interpersonal skills and work ethics.
• Attention to details is necessary.
• Must be a collaborator and can also work independently.
• Strong problem solving, critical thinking, decision making, verbal and written communication skills.
• Must be able to manage multiple projects concurrently.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.