Sr. Manager - GMP Quality Assurance

REMOTE

About Civica

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration’s shortage list. Manufacturing challenges and predatory pricing are both the cause and result. 

Who suffers most? Patients. 

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Led by an experienced team of health care and pharmaceutical industry leaders. 

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 U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. 

Civica is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” 

Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs. 

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.

https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189

Intro to Civica

https://vimeo.com/646267406

Job Description:

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 leading the quality oversight within the Quality System to ensure compliance with cGMP requirements, SOPs and regulatory standards for Civica’s commercial products. Furthermore, the role is responsible for providing quality management oversight to Civica’s quality management system policies and procedures.  The Senior Manager, Quality Assurance 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 (10) years related experience in managing quality assurance processes for commercial dug product manufacturing.  As a leader, the Senior Manager possesses competencies including, but not limited to, continuous process improvement, analyzing information, strategic planning, written and verbal communication, instilling excellence, attention to detail, addressing complex situations and qualified to lead and manage all aspects of the quality assurance process for Commercial products.  

Essential Duties and Responsibilities:

  • Implements and maintains quality process to ensure the quality oversight of commercial products manufactured, packaged, tested and/or released by Civica and Civica affiliates.
  • Acts as a compliance resource to provide guidance and leadership around aseptic processing and towards resolution of complex deviations, quality investigations, CAPAs and change control; batch release, review and approve quality system documents related to manufactured products.
  • Quality Oversight associated with the outsourcing of the development and technical transfer to the commercial manufacturing site of drug products.
  • Performs pre-approval inspection readiness for Civica products.  Supports regulatory agency inspections or third-party audits by participating in inspection preparation and provides audit support as necessary.
  • Keeps pace with emerging FDA requirements and regulations. Updates procedures and systems accordingly and tracks improvements to completion.
  • Provides technical support to Supply Chain and Quality in resolving issues associated with the manufacturing, packaging, release, and distribution of commercial products.
  • Implements risk-based qualification and governance practices for Civica’s commercial products; including establishing, maintaining and reporting on Quality performance indicators and prepares Civica Board and Quality Council quality performance metrics.
  • Establishes, oversees, expands, and maintain the Standard Operating Procedures (SOP) related to commercial distribution of drug product.
  • 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 or higher in a scientific discipline with a minimum of ten (10) years Quality Assurance/CGMP experience in the pharmaceutical industry.  Experience in the commercial distribution of pharmaceutical products required.  Experience with sterile injectable manufacturing of pharmaceuticals and biopharmaceuticals is required. Pharmacist or advanced degree highly desirable.
  • Minimum of 5-7 years’ experience in a supervisory role.  Minimum of 3-5 years managing Quality Management Systems and FDA inspection preparation and experience.
  • Experience with approving Investigations, Change Controls, Product Release, CAPA of external quality issues is required.
  • 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.
  • Must have detailed knowledge of cGMPs, CFR 210/211, DSCSA and applicable regulations/guidelines.