503B Pharmacy Quality Manager

Role Summary       

The Quality Manager is responsible for overseeing and maintaining the quality assurance (QA) and quality control (QC) programs in a 503B outsourcing facility. This role ensures compliance with FDA, cGMP (Current Good Manufacturing Practices), USP <797>, USP <800>, and DEA regulations. The Quality Manager will lead audits, manage investigations, and drive continuous improvement initiatives to uphold product safety, efficacy, and sterility     

Job Activities and Responsibilities: The responsibilities listed below are subject to change.

• Ensure compliance with FDA 21 CFR Part 210 & 211, USP <797>, USP <800>, and cGMP requirements.


• Demonstrate proficiency and follow Standard Operating Procedures related to sterile compounding, cleanroom operations and quality control.


• Develop and implement quality assurance procedures to ensure the quality of compounded medication, including but not limited to the materials, storage, preparation, and dispensing of compounded medication.


• Supervise environmental monitoring (EM), sterility, endotoxin, and particulate testing to ensure product safety


• Coordinate internal audits, supplier audits, and regulatory inspections, responding to findings with appropriate action plans


• Oversee QA/QC functions performed by compounding and quality personnel to ensure that procedures are followed and that all QA/QC tasks are properly documented.


• Work directly with Departmental Managers to assist with personnel training and compounding validations, including but not limited to scheduling, completing, and documenting all initial and ongoing Aseptic Process Simulations (APS), personnel skill assessments, didactic evaluations, and training plans.


• Oversee quality risk management, deviation investigations, CAPAs (Corrective and Preventive Actions), and change controls


• Work with Department Managers to evaluate patient complaints and adverse events, ensuring appropriate investigations and resolution.


• Oversees and maintains facility and equipment requirements, including but not limited to annual and biannual room certifications, monthly audits, equipment certifications, calibrations, and maintenance, and coordinates scheduling with Departmental Managers.


• Ensure proper validation of equipment, processes, and analytical methods used in production.


• Directly responsible for communication, documentation, and follow up with third-party laboratories regarding product testing, environmental sampling, and ongoing quality and stability study projects.

• Review and approve batch records, certificates of analysis (COAs), and release specifications


• Assist Departmental Managers with recalls of medications when applicable.


• Assist General Manager/Operations Manager with board of pharmacy, FDA, and accreditation inspections.


• Other duties as determined by General Manager and RPC QARA management.


• Lead and train cross-functional teams on cGMP, aseptic techniques, and contamination control.


• Act as a liaison between quality, production, and regulatory teams to maintain compliance and resolve quality-related issues.


• Drive continuous improvement initiatives to enhance efficiency, product quality, and regulatory readiness


• Other duties as determined by the General Manager
  

   

• Bachelor’s degree in Quality Assurance, Science, Medical Sciences, Pharmacology, etc., or an equivalent combination of education and experience is required


• A minimum of 3 years in a Quality Management, Quality Assurance, or related field


• Experience in pharmacy compounding or pharma manufacturing preferred


• In-depth knowledge and experience on FDA and applicable laws and regulations, as they relate to the industry, as well as of CGMP standards 21 CFR 210 and 211


• Strong understanding of quality management principles and procedures


• Proficiency in quality systems, CAPA management, and data-driven decision making


• Strong verbal and written communication skills (including analysis, interpretation, and reasoning)


• Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external stakeholders


• Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment


• Self-motivated with critical attention to detail, deadlines, and reporting


• Exceptional work ethic

Physical Requirements: 

• Ability to lift fifty (50) pounds. Moving, lifting, or carrying boxes. 


• Ability to stand for extended periods 


• Fine Motor Skills 


• Visual acuity 

Benefits:

• Health care insurance (medical, dental, vision)


• Life Insurance


• Supplemental Insurance 


• PTO


• 401K matching


• Sick leave

Revelation Pharma is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.


Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.