Quality Assurance-Commercial Distribution Senior Manager
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.
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.
The Senior Manager Quality Assurance 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 Senior Manager Quality Assurance is responsible for ensuring compliance with cGMP and regulatory requirements, and Civica procedures for Civica’s Private Label Distribution commercial products. Furthermore, the role is responsible for providing quality management oversight to Civica’s Private Label Distribution third party contract manufacturing organizations and supply partners as required. The Senior 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 Senior Manager Quality Assurance will have a minimum ten years related experience in managing quality assurance processes for commercial drug product manufacturing. As a leader manager possesses competencies including, but not limited to, continuous process improvements, analyzing information, strategic planning, written and verbal communication, instilling excellence, attention to detail, and addressing complex situations.
Essential Duties and Responsibilities:
- Oversees all activities associated with the quality assurance of Civica’s Private Label Distribution Commercial drug products. This includes oversight of third part contract manufacturers and the following Quality Systems: Change Control, CAPAs, QA holds, Deviations, Technical Complaints/Adverse Events, Performance Monitoring and internal inspection/auditing.
- Supports serialization processes and vendors in relation to DSCSA. Ensures serialization data meets the industry requirements for data integrity.
- Provides Quality oversight over software qualification, calibration and validation.
- Acts as a compliance resource to provide guidance and assistance around aseptic processing and towards resolution of complex deviations, quality investigations, CAPAs and change control; review and approve quality system documents related to manufactured drug products.
- Oversees all aspects of the complaint handling process; investigates product complaint investigation trends.
- Trains and mentors staff.
- Provides input and quality oversight over investigations, which includes review of investigation reports and associated corrective and preventative action (CAPA) plans and CAPA effectiveness.
- Participates in regularly scheduled meetings with Supply and Service Partners – both specific to QA and with cross-functional groups.
- Directs the development of processes and SOPs including support for development of processes and SOPs by process owners outside QA.
- Ensures compliance to internal SOPs and regulatory requirements as outlined under FDA, ISO, USP and CGMP guidelines.
- Supports regulatory agency inspections or third-party audits by participating in inspection preparation and provides audit support as necessary.
- Establishes, maintains and reports internal metrics to evaluate Quality performance for Commercial drug products.
- Works collaboratively with supply chain, quality assurance, commercial teams at Civica to ensure timely availability of all quality data and reports.
- Promotes a quality mindset and quality excellence approach to all activities.
- Other duties may be assigned as necessary.
Minimum Qualifications and Capabilities:
Bachelor’s degree in a scientific discipline is required, with a minimum of 10 years Quality Assurance/CGMP experience in the pharmaceutical industry. Experience in the commercial distribution of pharmaceutical drug products required. A licensed pharmacist would be preferred.
Minimum of 5-7 years’ experience in a supervisory role. Minimum of 3-5 years managing CMOs/Supply partners and driving process improvements.
Prior experience in the disposition and distribution of Commercial drug products.
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 sterile injectable manufacturing of pharmaceutical drug products is preferred.