Quality Assurance Manager - GPV and Clinical (Remote)
Company: Civica Rx
Posted on: March 20, 2023
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. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third 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 recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.
Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.
To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
The Quality Assurance (QA) Manager -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 - 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 - Clinical will have a minimum seven (7) years related experience in managing quality assurance processes for pharmacovigilance, product quality complaint, and clinical dug 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
Keywords: Civica Rx, Richmond , Quality Assurance Manager - GPV and Clinical (Remote), Executive , Petersburg, Virginia
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