Sr. Director, Quality at Meitheal Pharmaceuticals Inc

Chicago, Illinois, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Jan, 26

Salary

270000.0

Posted On

16 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, Inspection Readiness, Compliance, Partner Oversight, Quality Operations, Digital Quality, Data Governance, Leadership, Strategic Thinking, Problem Solving, Communication, Teamwork, Judgement, Dependability

Industry

Pharmaceutical Manufacturing

Description

Description 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. The Senior Director, Quality will provide strategic and operational leadership for Meitheal Pharmaceuticals’ Quality Management System (QMS) across generics, biologics, biosimilars, and device programs. This position will oversee quality operations, partner quality oversight, inspection readiness, and continuous improvement initiatives to ensure compliance with regulatory requirements. The Senior Director will work cross-functionally with Regulatory Affairs, Operations, Pharmacovigilance, and Commercial teams to drive inspection readiness, product launch quality, and global partner alignment. The role requires a balance of strategic leadership and hands-on operational execution to support Meitheal’s evolution from a generics-based organization to a biologic and biosimilars enterprise. The salary range for this position is $220,000 to $270,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 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. Quality Management System (QMS) Leadership · Lead the continued development and implementation of a fit-for-purpose QMS that supports generics, biologics, biosimilars, and devices. · Ensure all QMS elements (change control, deviation, CAPA, training, document control, complaint handling, and batch disposition) are implemented, compliant, and continuously improved. · 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. · Oversee preparation and coordination of regulatory inspections, mock audits, and partner audits. · 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. · Establish and maintain governance structures, KPIs, and performance monitoring for key partners (NKF, Kindos, and other affiliates). · 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). · Support product launch readiness, ensuring quality documentation, packaging validation, and stability data are in place. · 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. · Drive data integrity, audit trail management, and computerized system compliance per 21 CFR Part 11 and Annex 11. · 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. · Foster a proactive, solution-oriented, and collaborative Quality culture across the organization. · Represent Quality in cross-functional governance committees and decision-making forums. Competencies · Planning and Organizing · Communication · Strategic Thinking · Teamwork · Problem Solving · Quality · Judgement · Dependability 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. · Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Company’s 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/or 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.

Responsibilities

The Senior Director, Quality will lead the Quality Management System (QMS) and ensure compliance with regulatory requirements across various product lines. This role involves strategic leadership and operational execution to support the company's transition from generics to biologics and biosimilars.