Associate Director of Commercial Quality

4 weeks ago

Chicago, United States Meitheal Pharmaceuticals Inc Full time
Job DescriptionJob DescriptionDescription:

About Us:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.


Position Summary:

We are seeking an Associate Director, Commercial Quality, to join our QA team. The Associate Director of Quality position provides Quality Assurance oversight for operational aspects of the Quality department including commercial product shipments and distributions and change control management as well as ensures compliance with required regulations.


Key Responsibilities:

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

  • Management and Oversight of Quality Assurance Specialists, Commercial Quality and Change Control.
  • Responsible for the quality oversight of Meitheal's contract manufacturers.
  • Provides quality oversight for Commercial Quality life cycle management by conducting/reviewing Packaging Assessments and Shipping Assessments and reviewing Process Validation protocols/reports for commercialized product.
  • Oversees the batch review process and reviews and approves batch records as needed.
  • Oversees the batch shipment and distribution process and Reviews Quality documentation, Certificates of Analysis, Certificates of Conformances and Specification sheets, as needed.
  • Reviews internal and external Quality Events including deviations, investigations and risk assessments.
  • Oversees the change control process and performs final Quality Review.
  • Collects, trends and reports Partner Scorecard data.
  • Provides ongoing support to the existing QMS.
  • Collaborates with Product Launch Quality to support New Product Launches, as needed.
  • Supports management during external inspections
  • Provide guidance and support in all aspects of cGMP to our Partners.
  • Remains current in regulatory trends and requirements.

Supervisory

  • QA Specialist direct reports

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.

  • Adapt 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.
  • Experience communicating with global teams is preferred.
  • Ability to manage indirect relationships and projects successfully.
  • Elevates issues to management, when appropriate.

Education and/or Experience

  • Bachelor's degree in life sciences from 4-year college or university.
  • 10 years or progressive, challenging QA/QC experience in the pharmaceutical or related industry.
  • Excellent knowledge of current GMP and GLP as well as FDA trends and guidelines.
  • Strong interpersonal skills.
  • Great attention to detail is necessary.

Preferred

  • Background in aseptic processing, preferably with injectables.
  • Experience with complex generics, drug-device combination productions, biosimilars, or biologics is a plus.

Computer Skills

  • Proficient in Microsoft Office, Adobe Systems (Pro, Acrobat DC)
  • Quality management systems (TrackWise) preferred but not required.

Why Join Us?

  • Be part of a fast-growing company dedicated to making healthcare more accessible and affordable.
  • Work in a collaborative and supportive environment that values teamwork and common goals.
  • Opportunity to make strategic decisions and have a significant impact on the company's product offerings.
  • Hybrid schedule – two days in the office per week.
  • Casual dress code.

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.

Apply Now:

If you are passionate about Quality Assurance and want to contribute to a company that values innovation and teamwork, we want to hear from you Submit your resume and cover letter today to join our dedicated team at Meitheal Pharmaceuticals.

Requirements:


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