503B Pharmacy Quality Manager

Job Description

Job Description

Role Summary

The Quality Manager is responsible for overseeing and maintaining the quality assurance (QA) and quality control (QC) programs at Eagle Pharma Outsourcing. This role ensures compliance with FDA cGMP (Current Good Manufacturing Practices), associated FDA Regulatory Guidance Documents, ICH Guidelines, DEA regulations , and other relevant industry standards.

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

• As Quality Manager for Eagle, you will be responsible for leading the Quality Department. In support of the growing platform of products, you will bring deep expertise and experience into the rapidly expanding realm of 503B Outsourcing Facilities. This expertise will enable Eagle to continue to grow as a competitive and agile business in the categories that it operates within.

  As Quality Manager, you will execute end-to-end quality support that will help grow and protect the business. As a voice for quality compliance, you will support the strategic internal and external-facing connections, ensuing Eagle’s position as the industry leader in this area. Responsibilities include:

  • Ensure compliance with FDA 21 CFR Part 210 & 211, and cGMP requirements.
  • Manage and continuously improve Quality Assurance and Quality Control programs and procedures in accordance with CGMP and associated 503B Guidance Regulations. Programs include but are not limited to:
    1. Product Release
    2. Document Management
    3. Specifications
    4. Change Control
    5. Supplier Qualification
    6. Deviation/Non-Conformance
    7. CAPA
    8. Training
    9. Product Quality Complaints
    10. Adverse Events
    11. Product Stability
  • Development and implementation of quality assurance and quality control procedures to ensure the quality of compounded medication, including but not limited to the materials, storage, preparation, and dispensing of compounded medication
  • Continuously improve, develop and implement Quality Standard Operating Procedures (SOPs) ensuring compliance with the company’s policies and FDA regulations
  • Champion continuous improvements to our Quality Systems, implementing value-added standards and procedures to protect the brand while driving growth and ambition
  • Ensure the company is prepared for regulatory inspections and perform internal audits
  • Lead (with the General Manager and Operations Manager) FDA, state board, accreditation and other regulatory inspections and respond to findings with appropriate action plans
  • Review and approve specifications such as testing, packaging, and formula specifications
  • Develop and oversee environmental monitoring (EM) plans; evaluate EM data as it relates to efficiency of processes and cleaning procedures
  • Oversee QQ/QC functions performed by compounding and quality personnel to ensure that procedures are followed and that all 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 and maintain 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 department managers
  • 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
  • Lead recall processes
  • Act as a liaison between quality, production, and regulatory teams to maintain compliance and resolve quality-related issues.
  • Define and monitor metrics to track compliance and process effectiveness.
  • Demonstrate the ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes teamwork, collaboration, motivation, consensus and team building
  • Provide coaching, mentoring, and training within the Quality Team
  • Maintain specialized product category knowledge
  • Other duties as determined by the General Manager

Qualifications and Education Requirements

• 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
• Must be able to come into the pharmacy Monday through Friday

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.