Quality Assurance Manager

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 and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress at www.civicarx.org

Job Description:

The Quality Assurance (QA) Manager -Global Pharmacovigilance (GPV) and Clinical, will lead Civica, Inc. ("Civica") pharmacovigilance, product quality complaint and clinical oversight functions in developing and supplying essential generic quality and biosimilar medicines by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance.

The QA Manager - GPV and Clinical is responsible for leading the quality oversight within the Quality System to ensure compliance with cGMP and GCP requirements, SOPs and regulatory standards for Civica's product portfolio across generics and biosimilars, including combination products.

The QA Manager - PV and Clinical will have a minimum seven (7) years related experience in managing quality assurance processes for pharmacovigilance, product quality complaint, and clinical drug product manufacturing and clinical trial-related activities. As a leader, the QA Manager possesses competencies including, but not limited to, continuous process improvement, analyzing information, strategic planning, written and verbal communication, instilling excellence, attention to detail, problem solving and addressing complex situations. The position is a remote role.

Essential Duties and Responsibilities:

• Establish and lead Civica pharmacovigilance and product quality complaint functions including but not limited to ensuring:
  • Quality and operations systems comply with FDA and other applicable regulations and requirements by providing support and guidance on the interpretation of regulations and industry best practices
  • Civica's third party provider for pharmacovigilance and product quality complaint reporting meets Civica and FDA requirements and regulations
  • Product quality complaints, adverse drug events, and medical device reports are reported and investigated with follow-up as necessary
  • QA support in inspection preparation and hosting pharmacovigilance related regulatory inspections, including pre-inspection and follow-up activities
  • Perform vendor qualification and re-qualification audits of pharmacovigilance and safety related vendors as needed to support business needs and ensure compliance

• Establish and oversee clinical study processes and procedures for oversight of third party contract research organizations engaged in conducting clinical studies for Civica product development.
• Provide Quality oversight to stages of clinical study related activities including but not limited to ensuring:

• • investigational drugs are shipped only to qualified investigators participating in the investigation, only after all essential documents (financial disclosure/certification, investigator CV, Form FDA 1572) have been received from the site and the protocol, study related documents, including informed consent, have been approved by the IRB or IEC, and only after the IND, if required, is in effect and not subject to clinical hold
  • Direct and oversee monitoring of the clinical investigation, select a qualified third-party monitor and approve the Monitoring Plan
  • Ensure that controls are in place for testing, release, labeling, storage, and shipment of clinical trial materials
  • Ensure the accountability of all investigational product and the return or destruction of all unused investigational product
  • Maintain or ensure the selected clinical research organization maintains complete and accurate study records in accordance with § 312.57
• Lead interactions with the product development personnel regarding clinical compliance matters
• Communicate compliance requirements at all levels
• Ensure visibility to and manage awareness of any noted deviations, issues or deficiencies by escalating to management
• Review of Civica Regulatory filings, Information requests and related reports and technical documentation for compliance with regulations, guidance, and industry standards
• Review and assess changes to regulatory requirements and industry best practices and facilitate implementation through new or revised processes
• Establish, monitor and track processes and metrics which measure the level of risk of studies, programs and sites
• Perform other related duties as required

Basic Qualifications and Capabilities:

• Minimum Bachelor of Science (B.S.), Nursing, or PharmD degree
• Over seven (7) years of experience in the pharmaceutical industry, preferably in Clinical Quality Assurance and Pharmacovigilance/Safety roles
• 3-5 years leadership experience managing GCP quality assurance and pharmacovigilance quality management systems
• Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
• Demonstrated understanding of GXP requirements for compliance with domestic and international regulations including those of the US FDA and other applicable agencies in biologics, oral solid dosage product and/or combination products
• Strong interpersonal, verbal and written communication skills including technical writing skills
• Must understand a variety of quality systems that support the product development lifecycle and post marketing arena
• Solid problem solving and critical thinking skills
• Previous experience in preparing for and hosting/responding to regulatory health authority inspections
• Ability to lead projects with minimal supervision required; to work independently and in a team-based environment
• Ability to effectively plan, organize, monitor, execute, and measure success of a project
• Ability to anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall program
• Demonstrated ability to develop and implement business processes and process improvements