QA Manager-ANDA Development
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica’s mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.
Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.
WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country’s most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.
With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023.
As we continue to grow, we have many exciting opportunities for multiple types of roles and with opportunity to progress YOUR career.
The Quality Assurance Manager will join the Civica, Inc. (“Civica”) team in developing and supplying essential sterile injectable generic quality medicines to our hospital members in the United States by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance. This position can be based from Civica’s Lehi, Utah location or can be remote within the United States. The Quality Assurance Manager will provide quality oversight within the Quality System, including but not limited to review and development of SOPs, protocols, reports, data and records generated to support the development and successful approval and commercialization of pharmaceutical medications that meet business and operational requirements. The Quality Assurance Manager will develop processes and procedures in support of the Quality Management system consistent with U.S. Food and Drug Administration (FDA) regulations and current good manufacturing practices (CGMPs). The Quality Assurance Manager will have a minimum eight years related experience in process improvement, analyzing information, strategic planning, verbal communication, informing others, emphasizing excellence, attention to detail, thoroughness, dealing with complexity and/or training and qualified to lead and manage all aspects of the quality assurance and control processes.
Essential Duties and Responsibilities:
- Establish and maintain appropriate development phase GMP compliance during sterile injectable and combination product manufacture, testing and stability.
- Review and assess production and testing methods, specifications, validation protocols for analytical methods and method validation, reference materials, test results and reports created during product development.
- Routine coordination and quality review of Contract Manufacturer Organization (CMO) Partners’ documentation including batch record review for compliance to facilitate timely disposition of product lots.
- Quality Systems: Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, QA holds, Deviations, Technical Complaints/Adverse Events, Management Reporting and Self inspection auditing, QA reporting and approval of GMP documentation.
- Quality Operations: Support GMP compliance and inspection readiness within organization.
- Reviews records to ensure data meets the industry requirements for data integrity.
- Provides Quality oversight over software qualification and systems validation.
- Ensures that procedures are being followed as outlined under FDA, ISO, USP and CGMP guidelines.
- Provides input and quality oversight over investigations, which includes review of investigation reports and associated corrective and preventative action (CAPA) plans.
- Partners with Quality team members to implement centralized processes and ensures compliance to industry standards and compendia requirements.
- Conducts internal and external audits to determine if work activities affecting quality are in compliance with established quality procedures and that quality management system is operating effectively.
- Participates in qualification and approval of suppliers and subcontractors.
- Promotes a quality mindset and quality excellence approach to all activities.
- Receives, initiates, investigates and draws conclusions on investigations and product complaint investigations and coordinates all aspects of investigation through closure and/or provide oversight for complaint handling process.
- Travel (up to 10-20%) may be required, including international travel.
Basic Qualifications and Capabilities:
- Bachelor’s degree in a scientific discipline with a minimum of 8 years Quality/CGMP experience in the pharmaceutical industry. Experience in the manufacture of sterile injectable pharmaceutical and combination products required
- Experience with analytical QC (method development, validation and sample analysis)
- Demonstrated quality experience with injectable pharmaceutical product experience
- Minimum of 2 years’ experience in a supervisory role
- Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment
- Ability to work autonomously within established guidelines, procedures and practices
- Committed to delivering high quality results, overcoming challenges and focusing on what matters.
- Continuously looking for opportunities to learn, build skills and share learning