Quality Assurance Manager

Overview

is a rapidly growing consumer technology firm operating a suite of healthcare businesses, including our flagship brands BlueChew and MOD. Our mission is to better patients' lives through innovative healthcare solutions. With a team of over 500 professionals across various specialties, we've built scalable pharmacy, telemedicine, and e-commerce platforms using cutting-edge technology. As we continue our accelerated growth trajectory, we're launching new products to expand our patient base and accelerate growth. Join us in tackling exciting challenges at the intersection of healthcare and technology.

We are seeking an experienced, detail-oriented Quality Assurance Manager to lead and elevate the QA operations at our compounding pharmacy facility. In this role, you will directly manage a team of Quality Assurance Specialists, driving rigorous compliance, process validation, and quality control standards across all pharmacy operations.

As our QA Manager, you will serve as the bridge between regulatory requirements, operational efficiency, and safety. You’ll be responsible for maintaining our high standards for cGMP/GADP compliance, overseeing batch record reviews, investigating deviations, and building a culture of continuous improvement across our team.

Join our team in Elmhurst, IL - we're looking for someone who truly values and enjoys working onsite, not just tolerates it.

Responsibilities

As a QA Manager, you will be responsible for quality-related activities at the facility associated with inspections, in-process and finished products, 3rd party testing, patient complaints, product investigations, and Corrective and Preventive Action (CAPA) plans.

• Lead announced and unannounced inspections.

• Oversee quality associate roles and responsibilities

• Oversee quality aspects of multi-site functions

• Assist in identifying potential quality risks and working with operations personnel to develop improvement opportunities

• Supports the development of in-process verifications are in place to ensure product weights, correct labeling & packaging, and monitors when applicable.

• Recommend and implement improvements in streamlining processes and procedures in the areas of compounding, change control, and documentation.

• Support Quality leadership in conducting strategic assessments (i.e. gap analysis) of quality metrics.

• Drive quality improvements.

• Oversee day-to-day activities related to environmental monitoring, preparation release testing, and contamination control.

• Assist in identifying and conducting quality-related events and work with applicable personnel to achieve goals.

• Assists in monitoring patient complaints and product investigations and documentation, helping to assess risk, identify root cause, and quarantine product.

• Conduct root cause analysis for audit observations, documentation, complaints, non-conformances, and in-process deviations with business partners.

• Executes action plans for product quarantine, destruction, rework, withdrawal/recall

• Reviews 3rd party testing laboratory results, as necessary

• Verify that raw materials COA meet specifications limits.

• Manages batch documentation, log records, test results, and good documentation practices

• Ensure maintenance of all required recordkeeping logs; visitor log, waste log,

• Ensure all product Active ingredient COA have been signed and filed for recordkeeping purposes

• Support Compliance Manager to maintain and run audits and reconciliations of records.

• Performs reviews and audits as assigned

• Manages safety programs and conducts safety audits as applicable. (Hazards Training Program, Spill Kits, Eye Wash)

• Provide technical assistance and guidance in areas of contamination control, environmental monitoring, and facility controls.

• Train, develop and lead the quality team in support of the quality management system.

• Manages onboarding new hires by initiating training.

• Responsible for the delivery of site yearly training activities and training for site Quality Systems

• Coordinate curriculum management and proactively identify roles within the organization that are impacted by changes to ensure colleagues are assigned the appropriate training including new hire training and ensure training compliance.

• Knowledgeable of current USP 795 regulations in collaboration with Compliance.

• Consult with managers in various groups to develop an appropriate curriculum.

• Develop, review, and execute SOPs, protocols, and reports related to pharmacy operations.

• Review routine change control requests

• Assist with:

• Managing and Maintain all SOPs, forms, and policies.

• Revising policies/SOPs to the extent that operations/procedures have changed.

• Under the direction of the compliance department revising policies with anticipated changes in regulatory requirements.

• Participates in handling regulatory inspections in concert with pharmacy

• Manage inspection readiness program and activities for the site, ensuring an inspection-ready state.

• Lead performance improvement plan for the facility.

• Apply extensive professional experience interacting with regulators and accrediting boards in the context of pharmacy inspections.

• Serves as a resource subject matter expert for staff concerning policies and procedures

• Responds to all staff questions, concerns, or suggestions.

• Coordinates with the upper management to ensure accurate information is communicated to staff

Qualifications

• Pharmaceutical manufacturing/Quality leadership experience

• Experience in Regulatory Inspections

• Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes

• Proactive approach and strong critical thinking skills

• Strong collaboration, relationship management, and interpersonal skills

• Excellent written and verbal communication

• Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as PDM, Quality Tracking, Trending, Documentum platforms

Perks

• 100% company-paid Medical, Dental, and Vision premium coverage for employees, plus.

• Short-Term Disability and Life Insurance

• 401(k) with company match

• Complimentary daily lunch provided on-site