Our Culture

Fairness, respect and inclusion sit at the core of our name. Our people are our greatest asset, so we are continually investing in our people, process improvement and technology to deliver the very best to our customers. As an organization, we are committed to inclusion, we own our limitations, and we value new and different ideas.

Eight Signs of a Strong Company Culture

Diversity & Inclusion

Meitheal is passionate about inspiring and maintaining diversity and inclusion in the workplace. Companies that embrace people for their talents and character regardless of age, gender identity, race, sexual orientation, physical or mental ability, ethnicity, and perspective are simply better places of business.

More important, creating an environment where everyone from any background can do their best work isn’t just the right thing to do: It is the smart thing to do.

Equal Opportunity

Meitheal provides equal opportunity employment to all employees and applicants for employment.

We further prohibit discrimination and harassment of any type at work without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Our equal opportunity employment policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Community Meitheal

What do today’s employees really look for in a company, and what are the best ways a business gives back? At Meitheal, those are questions we think about often – and strive to answer in the most meaningful ways.

We understand that today’s dedicated professionals in generics, specialty biopharma and women’s fertility desire qualities such as a good match of skills and position; opportunities to further learn and develop; an inspiring, progressive environment; and a culture of inclusion and diversity.

They also truly want to be a part of something greater – something that gives back and sustains. Meitheal shows its commitment to the community through various employee volunteer opportunities, fundraising, and partnerships with local non-profits.

Just a few of our specific community efforts include:

  • Tutors and board members of Tutoring Chicago, which tutors children of the city and Chicago Public Schools
  • Donors and volunteers for the Greater Chicago Food Bank and the Lakeview Pantry
  • Salvation Army Christmas Giving Tree, providing Christmas presents for children in foster care
  • Feed My Starving Children, packing and shipping meals for developing countries
  • Rosemont Operation North Pole, providing a Christmas experience for terminally ill children who are health-compromised and their families
  • Active partnerships with the Direct Relief Agency, donating our drug products throughout the year during times of crisis or need

Our Benefits

We strive to offer a robust benefits program that meets the needs of each of our team members.
Just a few of the many benefits we offer include:

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Extensive Health
Offerings Including
Medical, Dental, Vision

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Paid Time Off (PTO)

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Company Paid
Holidays

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Onsite Gym
Membership

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401K Retirement
Savings Plan

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Annual
Performance-Bonus
Opportunity

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Short- and Long-Term Disability

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Paid Parental
Leave

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Employee Wellness
Resources

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Flexible Work
Arrangements

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Competitive
Wages

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Life and AD&D
Insurance

Have questions?

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Careers

We love to empower the careers of those who are committed, curious, collaborative, and courageous.

At Meitheal, we are united by our mission to provide easy access to fairly priced products. Meaningful work creates a meaningful career. With this, we provide the opportunity to not only improve the quality of life for patients, but for you to grow professionally as well. We embrace the diversity of our employee culture and the contributions that come from this.

By providing insightful guidance and fostering an environment of empowerment and collaboration, we celebrate our successes together. Our award-winning culture and exceptional team give us much to be proud of.

We are growing rapidly, so check back often!

Summary

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 include 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.


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 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.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

Company Overview:

At Meitheal Pharmaceuticals, we are dedicated to delivering high-quality generic and biosimilar pharmaceutical products to improve patient outcomes worldwide. With a commitment to excellence and innovation, we strive to set new standards in the pharmaceutical industry. As we expand our portfolio and global presence, we are seeking a dynamic and experienced Vice President of Quality Assurance to join our team and lead our quality initiatives.


Position Overview:

As the Vice President of Quality Assurance, you will play a pivotal role in shaping and implementing our quality strategy across all aspects of our operations. Reporting directly to the executive leadership team, you will be responsible for ensuring compliance with regulatory requirements, fostering a culture of continuous improvement, and maintaining the highest standards of quality throughout our organization.

Essential Duties and Responsibilities

Company Overview:

At Meitheal Pharmaceuticals, we are dedicated to delivering high-quality generic and biosimilar pharmaceutical products to improve patient outcomes worldwide. With a commitment to excellence and innovation, we strive to set new standards in the pharmaceutical industry. As we expand our portfolio and global presence, we are seeking a dynamic and experienced Vice President of Quality Assurance to join our team and lead our quality initiatives.


Position Overview:

As the Vice President of Quality Assurance, you will play a pivotal role in shaping and implementing our quality strategy across all aspects of our operations. Reporting directly to the executive leadership team, you will be responsible for ensuring compliance with regulatory requirements, fostering a culture of continuous improvement, and maintaining the highest standards of quality throughout our organization.

Supervisory Responsibilities

This position manages all employees of the department and is responsible for the performance management and hiring of the employees within that department.

Qualifications

What you need to be successful:


  • Bachelor's degree in a scientific discipline required; advanced degree preferred.
  • Minimum of 15 years of experience in the pharmaceutical/biotechnology sector, with at least 10 years in a leadership role within Quality Assurance.
  • Expert knowledge of FDA regulatory requirements, ICH guidelines, and industry standards.
  • Proven track record in successfully managing inspection readiness programs and regulatory inspections.
  • Strong leadership skills with the ability to influence and effect change within the organization.
  • Excellent communication and collaboration skills, with the ability to build strong working relationships cross-functionally.
  • Demonstrated ability to drive results and improve business performance.
  • Willingness to travel up to 25%, domestically and internationally.


What You’ll Love About our Company:



  • Watching your hard work have a direct impact on the success of the company. 
  • Hybrid Work Environment.
  • Competitive Pay.
  • Medical, dental and vision insurance.
  • 401K Company Match.
  • PTO and paid holidays.
  • Company paid wellness resources and fitness programs.
  • Relaxed, casual dress code.


 

AAP/EEO Statement

Equal Opportunity Employer:



Women/Veterans/Disabled.


Meitheal Pharmaceuticals is an equal opportunity employer committed to diversity and inclusion in the workplace. We welcome applicants from all backgrounds and strive to create a supportive and inclusive environment for all employees.



If you are passionate about quality and eager to make a difference in the pharmaceutical industry, we encourage you to apply for the Vice President of Quality Assurance position at Meitheal Pharmaceuticals. Join us in our mission to improve patient lives through excellence in quality and innovation. Apply now!



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