Quality Assurance Manager-GXP Computer Systems - Civica Rx

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

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 medicines 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 Computerized System Validation (CSV) of Civica’s GXP Computerized Systems including Veeva Vault (QDocs/Training/QMS/RIM/LIMS), DocuSign, excel, and Deacom. 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 andGAMP5. 

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 in 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%).