Quality Assurance - External Supplier Oversight Manager

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Job description

WHY CIVICA?

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 opportunities to progress YOUR career.

To find out more about how Civica's innovative model is directly impacting patient care, click here to read a recent article from the New England Journal of Medicine.

Commentary: The Health Care Utility Model: A Novel Approach to Doing Business

Intro to Civica

Job Description

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.

Preferred Qualifications:

Experience with commercial distribution of pharmaceuticals is preferred. Experience with quality support of serialization processes is preferred.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.

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