Director of Quality (Quality Systems)

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 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 #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good.

Learn more about who we are and what we do at www.meithealpharma.com.

Learn about our benefits at Meitheal Benefits

Position Summary:

The Director of Quality, Quality Systems, position provides oversight for Meitheal's Quality System processes including Document Management, Training Management, Complaint Investigations, Quality Events, CAPA, Risk Management, Field Alerts and Recalls. This position ensures Meitheal maintains a state of compliance for Meitheal's Quality systems. This position leads or actively participates in implementation of or updates and enhancements to these processes including monitoring emerging or changing regulations related to pharmaceuticals, biologics, and combination products and applying them as necessary. Oversee the intake, processing and review of Product Complaints and Inquiries. Collaborates with Meitheal's Pharmacovigilance department, as needed. Manages mock recall process and manages/participates in field alerts or product recalls, as needed. Leads continuous improvement efforts and CAPA management, as applicable.

Payrate is determined by considering a person's prior experience and competence.

Why Work with Us?

* Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

* Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

* Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

* Professional Growth: We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Lead, direct, oversee and mentor direct reports and their respective functions.
• Provide guidance and direction to Controlled Document owners on procedures and requirements for meeting applicable regulations and standards.
• Create, Review and Approve New Controlled Documents, as necessary.
• Update, Review and Approve existing Controlled Documents, as necessary.
• Conduct Final Quality Approval of Controlled Documents in TrackWise Digital.
• Ensure a robust and effective training program.
• Provide oversight of the preparation and presentation of Annual GMP Training.
• Collaborate with department management on the development of training plans.
• Evaluate training metrics and identify opportunities for improvement.
• Manage and oversee product quality complaint and inquiry intake and processing.
• Review and approve product quality complaint investigations.
• Provide Product Complaint Coordination and oversight for Multiple Suppliers for Branded Products.
• Review and approve Quality Events, deviations, and investigations.
• Facilitates Corrective and preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring, as needed.
• Participates in authoring, collaborating and approval of Quality risk assessments.
• Serves as the in-house Risk Management operations expert.
• Responsible for preparation of Field Alert Reports (FAR) in collaboration with manufacturing partners, as needed.
• Support management with Recall Committee meetings.
• Conduct Mock Recalls in accordance with Meitheal's procedures.
• Responsible for Recall activities, as needed.
• Lead and direct continuous improvement projects for applicable functions, as needed.
• Provide support to other areas within Quality, as needed.
• Remain current in regulatory trends and requirements.

Supervisory

Supervisory responsibilities include one or more direct reports.

Competencies

• Business Acumen
• Judgement
• Change Management
• Project Management
• Ethics
• Interpersonal

Qualifications

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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Assimilates to changing environments.
• Ability to prioritize and multitask.
• Organized and detailed orientated.
• Strong written and communication skills.
• Has a sense of urgency to meet all required deadlines.
• Knowledge of CGMP and GDP as well as FDA trends and guidelines.
• Strong interpersonal skills required.
• Elevates issues to management, when appropriate.

Education and/or Experience

• Bachelor's degree from 4-year college or university.
• 12+ years of progressive, challenging QA experience in the pharmaceutical industry.
• Excellent knowledge of current GMP and GLP as well as FDA trends and guidelines.
• Strong interpersonal skills and great attention to detail; background in aseptic processing, preferably with injectables.
• Experience with complex generics, drug-device combination productions, biosimilars, or biologics is a plus.

Travel

5%

Computer skills

Proficient with PC based word processors, databases and spreadsheets. Previous work experience with Electronic Quality Management Systems preferred.

Equal Opportunity Employer:

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.