QA Manager, CSV

1 week ago

durham, United States CARsgen Therapeutics Full time

Position Summary:

The QA Manager, Computer System Validation (CSV) & Data Integrity (DI) manages the computer system validation program, policies, and procedures. The QA Manager, CSV & DI ensures the procedures and validations related to computer systems align with the regulatory requirements. The role is a subject matter expert for the site related to computerized systems and data integrity for computer based systems and paper based systems.


Responsibilities:

  • Manage all aspects of the Computer Systems Validation (CSV) program. Develop, maintain, comply, and support CSV policies and procedures.
  • For computer systems that require verification, need to provide comprehensive and specific verification requirements, and make independent judgments whether it is during system selection, personalized customization, or self-development.
  • Implement and meet global requirements while ensuring the highest level of compliance with regulatory agencies. Track changes to the regulatory environment and implement processes and procedures enabling CARsgen to meet ongoing requirements such as 21 CFR Part 11, EU Annex 11, and MHRA data integrity guidelines. Independently manage projects and make sound decisions related to product quality issues.
  • Ensure compliance and update as required the CARsgen Validation Master Plan for all computer systems. Maintain compliance and enhance computerized system validation (CSV), policies, standards, processes, SOPs and other documents, and provide guidance and counsel as needed. Key player in the development, implementation, and maintenance of cGMP quality operational processes for the manufacturing of cell therapies.
  • Manage the execution and documentation of the CSV Program. This includes all CSV activities, documentation requirements, and reports including plans, risk assessments, function requirements, periodic reviews, configuration specifications, testing, change controls, traceability matrix, qualification protocols, validation, and compliance reviews.
  • Ensure project deadlines and performance standards are met while communicating status;
  • Serve as the CSV SME during audits and for any standards.
  • Data Integrity – Developed a culture of data integrity excellence by ensuring appropriate systems and processes are in place to support GMP data integrity. Ensured equipment meets requirements for data integrity security.
  • Subject Matter Expert for all data integrity inquiries, monitor and maintain the site data integrity plan reporting to site leadership and senior management.
  • Setup and maintain a site network team of functional Data Integrity SMEs within GMP functional areas of Manufacturing, Maintenance, Manufacturing Science and Technology (MS&T), Engineering, and Quality Assurance Operations.
  • Continuously improve data integrity knowledge base, identify training needs with appropriate training materials, and engage in shop floor communications to strengthen quality culture.
  • Data Control Strategy – Development and implementation of data control strategy for manufacturing and laboratory equipment
  • Ensure site support for investigations, rapid alerts, reviews, and audits focused on internal and external DI.
  • Manage regulatory and health authority inspections and response to DI related topics.


Qualifications:

  • Bachelor’s degree in engineering, Information Technology, Computer Information Systems, Information Systems Technologies, or related field.
  • Minimum of 7 years’ experience in Computer System Validation, Engineer, or Data Integrity related role.
  • With related working experience in Cell Gene therapy is plus.
  • Knowledge of cGMP regulations and FDA guidance’s applicable to biologics and cell therapies.
  • Excellent communication, trouble shooting, and problem-solving skills.
  • Strong team player that can work independently to achieve objectives.
  • Detail oriented, with strong good documentation practices expertise.
  • Ability to effectively prioritize and manage multiple projects and tasks.
  • Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
  • Mentor staff and build processes that will drive innovation, teamwork, and efficiency within the organization.

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