QA Manager-External Supplier Oversight, Commercial Sterile Injectables
Civica is a rapidly growing and entrepreneurial nonprofit generic drug company created in September 2018 to reduce and prevent drug shortages and the price spikes that can accompany them. Its mission, as driven by its governing board of hospital systems and philanthropies, is to make quality generic medicines accessible and affordable to everyone.
Civica is improving patient outcomes and reducing healthcare costs.
Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent of all U.S. hospital beds. Civica has also begun to supply the Veteran’s Administration, the Department of Defense, and the U.S. Strategic National Stockpile essential medicines.
In less than two years, Civica has secured 40 different medications and provided over 2 million vials of sterile injectable essential medicines to the Strategic National Stockpile.
Civica is building a 100 million dollar state-of-the-art manufacturing plant. Join us to help serve patients!
The Quality Assurance Manager will join the Civica, Inc. (“Civica”) team in supplying essential 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.
The Quality Assurance Manager will provide quality oversight within the Quality System, including but not limited to review of SOPs, protocols, reports, data and records generated to support the disposition and distribution of pharmaceutical product to meet business and operational requirements. The Quality Assurance Manager will develop processes and procedures in support of the Quality Management system consistent with Food and Drug Administration (FDA) regulations and current good manufacturing practices (CGMPs).
The Quality Assurance Manager will have a minimum five (5) 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 control process.
Essential Duties and Responsibilities:
- 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 Monitoring and Self inspection auditing, QA reporting and approval of GMP documentation.
- Quality Operations: Support CGMP compliance and inspection readiness within organization.
- Reviews records to ensure data meets the industry requirements for data integrity.
- Provides Quality oversight over software qualification, calibration and 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.
- Conducts internal and external audits to determine if work activities affecting quality are in compliance with established quality procedures and that the 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.
- Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and/or provide oversight for complaint handling process.
- Monitor serialization processes and vendors in relation to DSCSA.
Minimum Qualifications and Capabilities:
Bachelor’s degree in a scientific discipline with a minimum of 5 years Quality/CGMP experience in the pharmaceutical industry. Experience in the manufacture of sterile injectable pharmaceutical products required.
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.
Experience with commercial distribution of pharmaceuticals is preferred. Experience with quality support of serialization processes is preferred.