503A Quality Assurance Manager at Revelation Pharma LLC

Benefits:

• Health care insurance (medical, dental, vision)
• Company Paid Life Insurance
• Supplemental Insurance
• PTO
• 401K matching
• Sick leave
• Phone/internet reimbursement
• Remote work
• Bereavement Leave
• Paid Holidays
• Paid Jury Duty

The primary function of the Quality Assurance Manager is to maintain quality systems, drive continuous process improvement, and ensure compounding is performed according to regulatory standards and industry best practices for all assigned 503 A compounding pharmacies in the Revelation network.

• Works with senior leadership to develop, implement, and maintain successful RPC quality and regulatory strategies for corporate quality systems and respective pharmacies, including:
  1. Articulating quality standards and objectives to pharmacies and RPC departments
  2. Developing methods to embed quality into compounding processes for 503A facilities
  3. Establishing vendor relationships and standards
  4. Overseeing processes for internal and external quality audits
  5. Maintaining inspection readiness and responding to findings from audits

• Develop, implement, and maintain SOPs, training and competency assessment material, and gap analysis tools
• Proactively partner with R&D, Marketing, Clinical and other RPC teams to provide regulatory advice and guidance on meeting necessary requirements
• Oversee employee development, processes, and technology necessary to reach annual and long-term objectives established by executive leadership and the Board of Directors
• Works alongside RPC departments to support corporate goal of instilling a Culture of Excellence, Financial Performance, and Focus on Quality with all RPC employees

• Bachelor’s degree preferred
• Minimum of 5 years of experience in quality leadership roles
• 3 years of experience in compounding pharmacy or related field
• Extensive experience hosting regulatory inspections and interacting with regulatory bodies.
• Broad knowledge base of cGMP, FDA, USP, GFIs, CPGs and applicable regulations and industry standards regarding regulation of 503a compounding pharmacies.
• Effective leader with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management
• Public speaking and teaching ability, both in-person and through virtual platforms
• Proven ability to create culture of accountability and ownership

Physical Requirements:

• Proficient in using a computer and related equipment, including printers and fax machines.
• Ability to sit or stand for extended periods.
• Effective communication skills via telephone and email.
• Capable of lifting up to 40 pounds as needed.
• 20/20 vision (with or without corrective aids)

• Laptop and computer workstation
• Cell Phone
• Access to RPC software subscriptions

• EBITDA
• Revenue Projections
• Successful onboarding and integration of new RPC pharmacies
• Staff Attrition
• Employee Satisfaction
• Quality Assurance Program
  1. Successful inspections from internal and external audits, with timely response to all deficiencies
  2. Compliance with USP, state and federal regulatory requirements
  3. Maintenance of compliance with RPC SOPs
  4. Best practice application of industry standards
• Minimal production disruption due to regulatory or process non-compliance