POSITION TITLE: Quality Assurance Manager
REPORTING TO: VP Pharmacy Operations
POSITION TYPE & LOCATION: Full-time, Exempt position based in Henderson, NV
Position and Scope
The Quality Assurance Manager is responsible for overseeing all aspects of the quality system within ’s 503B outsourcing facility to ensure full compliance with FDA regulations, and current Good Manufacturing Practices (cGMP). This role ensures that compounded products are manufactured, tested, and released in accordance with approved procedures and regulatory expectations, with an emphasis on patient safety, product integrity, and operational efficiency.A key focus of this role is the ability to produce clear, accurate technical documentation and to lead initiatives aimed at continuous quality improvement. The Quality Assurance Manager will play an integral role in supporting Company’s mission of delivering safe, high-quality medications to patients. This position reports directly to the Director of Quality and serves as a leader within the Quality Unit, guiding daily QA operations and managing a team of quality professionals. Essential Duties and Responsibilities
· Manage and maintain the facility’s Quality Management System (QMS), including deviation management, CAPA, change control, complaint handling, NCR, and product release.
· Ensure batch records, logbooks, SOPs, and other quality documentation are compliant, accurate, and up-to-date.
· Directly manage and develop QA team members, including assigning responsibilities, monitoring performance, and supporting professional growth.
· Ensure adequate staffing and training to meet operational and regulatory needs.
· Foster a quality-driven culture through coaching, mentoring, and day-to-day leadership.
· Lead investigations of deviations, OOS results, and non-conformances; determine root causes and approve corrective/preventive actions.
· Conduct risk assessments and escalate critical quality or compliance issues appropriately.
· Prepare for and support FDA inspections and internal/external audits.
· Conduct internal audits of the facility, quality systems, and operational practices.
· Oversee document control processes and ensure controlled distribution and archival of GMP records.
· Ensure all personnel are trained on applicable SOPs, cGMP requirements, and regulatory expectations.
· Support ongoing training initiatives and monitor compliance to training requirements.
· Oversee vendor qualification programs and ensure incoming materials meet quality specifications.
· Review and approve batch records for accuracy, completeness, and compliance prior to product release.
· Ensure that all specifications are met and appropriate testing is performed.
· Identify trends in deviations and complaints and drive continuous improvement initiatives.
· Owner of monthly QMR meeting including metric and trending, gaps, issues and resolutions
· Participate in quality review meetings and propose system or procedural enhancements.
Skills and Experience Required
· Bachelor’s degree in pharmacy, chemistry, biology, or a related life science discipline.
· 5–7 years of progressive quality experience in a cGMP-regulated environment, preferably in a 503B outsourcing facility or sterile manufacturing setting.
· Strong understanding of FDA regulations, 503B guidance, and related cGMP requirements.
· Demonstrate experience applying cGMP principles and a strong grasp of relevant industry concepts, practices, and procedures.
· Prior experience working collaboratively with Production or Manufacturing teams.
· Proven leadership, organizational, and problem-solving abilities.
· Excellent verbal and written communication skills.
· Exceptional attention to detail and accuracy.
· Proficiency in computer systems, including Microsoft Office (Word, Excel, Outlook), Adobe, inventory management platforms, and electronic Quality Management Systems (eQMS).
· Ability to work both independently and collaboratively in a fast-paced, small-team environment.
· Strong time management skills with the ability to multitask and meet deadlines effectively
Additional Notes
· Must be willing and able to gown for ISO 8 area.
Please note, this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Additional duties and tasks can be assigned by management when the need arises.
Pay: $75,722.00 - $91,192.09 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
Work Location: In person
