Meitheal Pharmaceuticals, Inc.
Sr. Director, Quality
Meitheal Pharmaceuticals, Inc., Chicago, Illinois, United States, 60290
About Meitheal Pharmaceuticals
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 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.
Job Title: Senior Director, Quality Job Type: Full‑time
Salary range: $220,000 – $270,000
Responsibilities
QMS Leadership:
Lead the continued development and implementation of a fit‑for‑purpose QMS that supports generics, biologics, biosimilars, and devices.
QMS Leadership:
Ensure all QMS elements (change control, deviation, CAPA, training, document control, complaint handling, and batch disposition) are implemented, compliant, and continuously improved.
QMS Leadership:
Drive QMS remediation and sustainment activities based on internal audits and gap assessments.
Inspection Readiness & Compliance:
Lead the development and execution of Meitheal’s inspection readiness strategy, ensuring continuous compliance with FDA, ICH, and international standards.
Inspection Readiness & Compliance:
Oversee preparation and coordination of regulatory inspections, mock audits, and partner audits.
Inspection Readiness & Compliance:
Serve as a key contact for regulatory agencies during inspections and audits.
Partner & Supplier Quality Oversight:
Provide oversight of all contract manufacturing organizations (CMOs), testing laboratories, and suppliers to ensure compliance with cGMP and Quality Agreements.
Partner & Supplier Quality Oversight:
Establish and maintain governance structures, KPIs, and performance monitoring for key partners (NKF, Kindos, and other affiliates).
Partner & Supplier Quality Oversight:
Lead resolution of quality issues, CAPAs, and audit findings in collaboration with partners.
Quality Operations & Product Support:
Support change control, complaint handling, and annual product quality reviews (APQRs).
Quality Operations & Product Support:
Support product launch readiness, ensuring quality documentation, packaging validation, and stability data are in place.
Quality Operations & Product Support:
Provide quality leadership for lifecycle management and post‑market quality programs.
Digital Quality & Data Governance:
Support digital QMS initiatives including TrackWise Digital, ValGenesis, and other validated systems.
Digital Quality & Data Governance:
Drive data integrity, audit trail management, and computerized system compliance per 21 CFR Part 11 and Annex 11.
Digital Quality & Data Governance:
Collaborate with IT and business functions to enhance data governance and analytics.
Leadership & Culture:
Lead, mentor, and develop the Quality Systems and Compliance teams to build technical expertise, accountability, and engagement.
Leadership & Culture:
Foster a proactive, solution‑oriented, and collaborative Quality culture across the organization.
Leadership & Culture:
Represent Quality in cross‑functional governance committees and decision‑making forums.
Benefits
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.
Qualifications
Demonstrated leadership to drive results that are needed to achieve company objectives in accord with company culture and core values – courageousness, creativity, selflessness and humor.
Strategic thinker with the ability to execute operationally.
Excellent communicator and collaborator with strong analytical and problem‑solving skills.
Demonstrated ability to lead cross‑functional initiatives in a matrixed, global environment.
Influence and effect change within the organization.
Demonstrate excellent written and verbal communication skills.
Education and Experience
Minimum of a bachelor’s degree in a scientific discipline; advanced degree preferred.
Minimum 15 years in pharmaceutical or biotechnology Quality Assurance.
Minimum 7 years in a leadership role with demonstrated success managing quality systems and partner oversight.
Experience with biologics/biosimilars and combination products strongly preferred.
Prior experience with virtual or outsourced manufacturing models (CMOs, CTLs, 3PLs).
Proven record of success during FDA inspections.
Strong knowledge of 21 CFR Parts 210, 211, 600–680, 820, and ICH Q7–Q12.
Understanding of data integrity, Annex 11, and GAMP 5 principles.
Hands‑on experience with TrackWise Digital, or similar systems.
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.
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Job Title: Senior Director, Quality Job Type: Full‑time
Salary range: $220,000 – $270,000
Responsibilities
QMS Leadership:
Lead the continued development and implementation of a fit‑for‑purpose QMS that supports generics, biologics, biosimilars, and devices.
QMS Leadership:
Ensure all QMS elements (change control, deviation, CAPA, training, document control, complaint handling, and batch disposition) are implemented, compliant, and continuously improved.
QMS Leadership:
Drive QMS remediation and sustainment activities based on internal audits and gap assessments.
Inspection Readiness & Compliance:
Lead the development and execution of Meitheal’s inspection readiness strategy, ensuring continuous compliance with FDA, ICH, and international standards.
Inspection Readiness & Compliance:
Oversee preparation and coordination of regulatory inspections, mock audits, and partner audits.
Inspection Readiness & Compliance:
Serve as a key contact for regulatory agencies during inspections and audits.
Partner & Supplier Quality Oversight:
Provide oversight of all contract manufacturing organizations (CMOs), testing laboratories, and suppliers to ensure compliance with cGMP and Quality Agreements.
Partner & Supplier Quality Oversight:
Establish and maintain governance structures, KPIs, and performance monitoring for key partners (NKF, Kindos, and other affiliates).
Partner & Supplier Quality Oversight:
Lead resolution of quality issues, CAPAs, and audit findings in collaboration with partners.
Quality Operations & Product Support:
Support change control, complaint handling, and annual product quality reviews (APQRs).
Quality Operations & Product Support:
Support product launch readiness, ensuring quality documentation, packaging validation, and stability data are in place.
Quality Operations & Product Support:
Provide quality leadership for lifecycle management and post‑market quality programs.
Digital Quality & Data Governance:
Support digital QMS initiatives including TrackWise Digital, ValGenesis, and other validated systems.
Digital Quality & Data Governance:
Drive data integrity, audit trail management, and computerized system compliance per 21 CFR Part 11 and Annex 11.
Digital Quality & Data Governance:
Collaborate with IT and business functions to enhance data governance and analytics.
Leadership & Culture:
Lead, mentor, and develop the Quality Systems and Compliance teams to build technical expertise, accountability, and engagement.
Leadership & Culture:
Foster a proactive, solution‑oriented, and collaborative Quality culture across the organization.
Leadership & Culture:
Represent Quality in cross‑functional governance committees and decision‑making forums.
Benefits
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.
Qualifications
Demonstrated leadership to drive results that are needed to achieve company objectives in accord with company culture and core values – courageousness, creativity, selflessness and humor.
Strategic thinker with the ability to execute operationally.
Excellent communicator and collaborator with strong analytical and problem‑solving skills.
Demonstrated ability to lead cross‑functional initiatives in a matrixed, global environment.
Influence and effect change within the organization.
Demonstrate excellent written and verbal communication skills.
Education and Experience
Minimum of a bachelor’s degree in a scientific discipline; advanced degree preferred.
Minimum 15 years in pharmaceutical or biotechnology Quality Assurance.
Minimum 7 years in a leadership role with demonstrated success managing quality systems and partner oversight.
Experience with biologics/biosimilars and combination products strongly preferred.
Prior experience with virtual or outsourced manufacturing models (CMOs, CTLs, 3PLs).
Proven record of success during FDA inspections.
Strong knowledge of 21 CFR Parts 210, 211, 600–680, 820, and ICH Q7–Q12.
Understanding of data integrity, Annex 11, and GAMP 5 principles.
Hands‑on experience with TrackWise Digital, or similar systems.
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.
#J-18808-Ljbffr