Quality Assurance Manager-GXP Computer Systems at Civica Rx

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 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.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Position Summary

The Quality Assurance (QA) Manager - GXP Computer Systems ("QA Manager") will join the Civica, Inc. ("Civica") team in supplying essential generic and biosimilar quality medicine by bringing their knowledge and experience to serve patients and pursue excellence in quality and compliance.

The QA Manager is a subject matter expert who will oversee the theComputerized System Validation (CSV) of Civica's GXP Computerized Systems including Veeva Vault (QDocs/Training/QMS/RIM/LIMS), DocuSign, rfxcel, and Deacon. The QA Manager also works with the Civica Petersburg, Virginia manufacturing and future testing laboratory sites relative to GXP-related computer systems and programs. The QA Manager is responsible for software quality oversight of system validation and verification efforts supporting areas that include ERP, QMS, RIM/Submission, serialization, computer-related instrumentation, equipment, and any future GXP-related software applications. The QA Manager will support Civica's quality and regulatory technology implementation and ensure the software and applications comply and adhere to regulatory expectations, such as 21 CFR Part 11, data integrity, current Good Manufacturing Practice (cGMP) guidance documents, and GAMP5.

This remote role reports to the Head of Quality Systems and will work closely with Civica's Quality, Supply Chain, Manufacturing, Engineering, and Regulatory teams. Change and stakeholder management across the business, and collaboration with senior leaders is a critical requirement of this role.

Essential Duties and Responsibilities

• Provide QA leadership for GXP computer systems and assures a risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, GAMP 5 and Civica Policies and Procedures.
• Support the overall readiness of the CSV program and computer-related systems to ensure software programs are compliant and ready for audits and regulatory inspections.
• Review/assess proposed GXP-related computer system change controls, investigations, CAPA, periodic reviews of GXP systems and system access in alignment with procedures to ensure compliance.
• Review and approve validation plans, protocols, reports and other verification/validation related documentation for GXP computer systems.
• Assess systems for data integrity and compliance with regulatory expectations including assessment of third-party IT service suppliers and applications.
• Participate in and support the external audit program for vendors related to GXP computerized systems.
• Provide QA guidance in the development and revision of GXP computer system procedures.
• Participate in cross-functional project teams in support of GXP computer system compliance.
• Work in collaboration with the system owners and administrators, to address priorities for programs and changes to GXP Computer system configuration, security, security profiles and any required migration plans for compliant implementation in alignment with organizational processes.
• Perform quality support duties including implementation, maintenance, and execution of quality management system processes in the Veeva.
• Provide ongoing Quality support, advice, and guidance to GXP related System Owners and System Administrators.
• Effectively manage priorities, multiple projects and ability to communicate with all levels of personnel.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor's Degree in Scientific discipline, Computer Science, or Information Technology. Masters preferred.
• 8+ years of relevant progressive experience, preferably within the pharmaceutical/biotech industry
• Comprehensive expertise and working knowledge of GXP requirements including 21 CFR Parts 11, Data Integrity, ISPE GAMP 5 and related standards and guidance documents.
• Preferred experience in validation for SaaS systems.
• Must have proven business and technology skills, with success providing customer-oriented technology solutions environment.
• Advanced skill level with Microsoft Office, especially Excel, Word, PowerPoint, and Outlook .
• Excellent verbal and written communication skills.
• Ability to read, understand, and follow complex instruction.
• People-oriented - enjoys interacting with people and working on group projects .
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• This is a remote role with occasional travel required (<10%).