About Civica
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 expanded its mission, via a unit called CivicaScript, 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 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 finalizing qualification activities and is preparing for manufacturing.
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.
(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)
Job Description:
The Vice President Quality, CivicaScript, is an executive matrix and influential leader who serves as the central point of quality and compliance contact for CivicaScript and associated product portfolio across internal stakeholders and external vendors / partners. Primary responsibilities include providing quality and compliance strategic direction and oversight in support of the designated product portfolio while establishing and maintaining alignment with Civica Inc.'s policies and practices. Reporting to the Chief Quality and Regulatory Affairs Officer (CQO), the Vice President Quality will ensure consistent product quality and regulatory compliance at third party manufacturing and service providers to assure reliable delivery of quality generic medicines to patients consistent with Civica's mission. This is a remote role.
Essential Duties and Responsibilities:
The Vice President Quality, CivicaScript, has the following key responsibilities:
- Assure quality and compliance processes are in place to deliver a robust pipeline of essential generic products for CivicaScript that are designed, submitted, approved and successfully perform meeting payer, patient and regulatory agency expectations and standards.
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Assure alignment of CivicaScript quality and compliance strategic direction with Civica, Inc.
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Provide operational direction and leadership for quality and compliance activities necessary to support the CivicaScript product portfolio.
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Assure effective quality and compliance oversight of activities performed by Civica and its third parties to support the CivicaScript portfolio.
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Develop and assure the timely reporting of key quality and compliance metrics for CivicaScript.
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Maintain an effective management escalation process and assure issues and events with potential product quality and compliance risk are reliably reported to the CQO and applicable members of the Civica leadership team.
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Establish and maintain effective working relationships with internal Quality and Regulatory professionals and those at third parties performing activities on behalf of CivicaScript.
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Continually assess the changing regulatory environment to evaluate the need to implement revised standards and processes that ensure product quality and drive sustainable supply and business success.
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Champion a culture that supports a high commitment to Quality and compliance excellence.
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Support Regulatory Affairs and product registration and maintenance activities to ensure the accuracy and timeliness of health authority communications and notifications.
- Identify end-to-end improvement opportunities across quality and compliance and assure implementation of appropriate risk mitigation and measures.
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Establish a network of subject matter experts and support talent acquisition and development.
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Actively participate as a senior Quality leader driving Civica's mission to do what is in the best interest of patients.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Minimum Qualifications (Knowledge, Skills, And Abilities):
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Minimum 20 years of life science/pharmaceutical experience including management of quality and compliance and other regulated functions in a global healthcare environment.
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Functional/technical knowledge of/and experience in quality and regulatory compliance and supply chain/operations.
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Previous industry experience at a global/international vice president level in-function required with demonstrated track record of successful results and talent leadership pipeline development.
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Previous direct experience interfacing and establishing strong relationships with global regulatory agencies, e.g., FDA, EMA, MHRA, DEA, etc., and a history of success and credibility resolving complex regulatory compliance topics.
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Bachelor's degree in a science or engineering discipline.
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Excellent interpersonal, verbal, and written communication skills.
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Proven success in:
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Strategic thinking capability with business acumen to allow an understanding of how the parts impact the enterprise
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Direct support of the submission and approval of regulatory applications, amendments and changes including resolution of information requests
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Large scale quality management experience including the design and implementation of effective and compliant quality processes, procedures and tools
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Exceptional problem-solving skills to foster the development and implementation of risk-based compliant solutions to business and regulatory challenges
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Providing quality and compliance input across the development and product lifecycle
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Process and analytical development and commercial knowledge to facilitate root cause analysis and effective solutions and corrective measures
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Quality and compliance support experience in the design, implementation and regulatory approval of network and footprint changes including capacity expansion and reduction
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Building and maintaining complex collaborative relationships capable of influencing the delivery of aligned compliant solutions and decisions
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Creating a future vision and gaining support and alignment to that vision
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Building consensus and impact outcome without always having line authority
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Negotiating trade off decisions across the organization
Physical Demands and Work Environment:
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Ability to travel in the U.S. and internationally, as needed, for contract manufacturing oversight and Civica manufacturing site. Travel of up to 25% may be required.