Lead Quality Computer System Validation (QCSV)

  • Company: Johnson & Johnson
  • Location: Spring House, Pennsylvania
  • Posted: March 01, 2017
  • Reference ID: 000018WU-en-us

The Johnson & Johnson Family of Companies is currently recruiting for a Lead Quality Computer System Validation (QCSV). This role can be remote, working from home, or at any Johnson & Johnson location within the United States or Europe. 

Johnson & Johnson Family of Companies. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

With $70.1 billion in 2015 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 265+ Johnson & Johnson operating companies employ approximately 126,500 people in 60 countries throughout the world.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Quality Computerized System Validation (Q-CSV) Center of Excellence ensures compliance of systems across the enterprise in accordance with the J&J Software Development Lifecycle and Computer System Validation methodologies, assures compliance within the enterprise with applicable global regulations, advise on quality matters, and assist with closing compliance gaps related to audits and inspections.

The Lead Q-CSV R&D is responsible for supporting GxP R&D IT project teams through the day to day project CSV activities under the supervision and direction of the Manager. The purpose of this role is to align and work closely with the system Project Manager for project planning and execution of CSV activities and completion of expected deliverables. 

Major Duties and Responsibilities:

Approximate Percentage of Time - Tasks/Duties/Responsibilities

  • Responsible for providing CSV guidance and support to project and/or base business support teams in the resolution of validation documentation corrections and/or test defects 
  • Perform pre and post review and approval of validation test scripts including test defects 
  • Review/approval of validation documentation deliverables such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix, and the Compliance Report including final release and approval for production use
  • Ensure a high degree of Inspection Readiness for Systems in Q-CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within Q-CSV responsibility
  • Act as backup project management staff as needed
  • Ensure a high degree of Inspection Readiness for Systems in Q-CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within Q-CSV responsibility
  • Participate in audits, approves audit non-conformity action plans 
  • Demonstrates an understanding of many relevant Quality and Compliance principles and their applications 
  • Work with the Q-CSV Manager in developing, monitoring and managing project costs, schedules, resources and quality

  • Leads and mentors a team of internal and external resources through the system lifecycle and utilizes expert knowledge regarding risk management practices. 
  • Assist or drive status meetings to communicate and address project risks or issues
  • Works collaboratively with project teams to keep them informed of project status, including any barriers 
  • Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
  • Defines internal standards to move the organization toward a more positive risk management posture by utilizing extensive knowledge of current and emerging best practices in risk management 
  • Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
  • Provide an environment which encourages the company's credo and diversity of opinions and thoughts
  • Ensure timely completion of assigned training and expense reporting
Other Duties:
  • Develop and maintain an effective working partnership with senior management.
  • Collaborate with other leaders and staff within Q-CSV group to ensure each function is executed in an efficient manner.
  • Ensure timely reports of status, metrics and time sheets as required by the Q-CSV organization.
  • Ensure timely completion of assigned training and expense reports.

  • An Associate’s Degree is required.
  • A Bachelor’s degree in Computer Science, Information Systems, Business Administration, the Sciences or other related field is a plus; additional certifications a plus.
  • A minimum of 5-7 of progressive experience in the Pharmaceutical / Medical Devices/ Biotech, Consumer Industry with direct experience in Computerized System Validation activities and QA Analysis is required. 
  • Preferred experience with R&D systems (pharma, consumer and/or medical device) supporting Clinical, Regulatory Affairs, Non-Clinical/Preclinical and Product Development business areas.  
  • The Q-CSV Lead is responsible for reviewing and approving validation deliverables of GxP regulated computerized systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams. 
  • This position will support internal and external Health Authority regulatory audits. 
  • Knowledge of SDLC Quality Management process and Computerized System Validation principles is required.
  • Working knowledge of SDLC, GAMP 5, is highly desirable.
  • Thorough knowledge of cGMP / GxP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211, part 58 and Part 820 and ICH E6 and/or E8 is required.
  • Working knowledge of Global regulations like ICH, MHRA, OECD, Annex 11, ISO preferred.
  • Experience in Testing Management Tools like HPALM is preferred and document management tools like Documentum, Veeva.
  • Superior written and oral communication and excellent Microsoft Office skills required.
  • Must have the ability to work effectively in a highly matrixed, virtual systems environment.
  • Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands.
  • Strong skills in interdependent partnering and influencing required.
  • Expert organizational skills are Preferred. 
  • Must have the ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding Quality.
  • Preferred Knowledge, Skills and Abilities: 
  • Experience interacting with health authorities and/or notified bodies during inspections is preferred.
  • Understanding of how regulatory bodies approach inspections and how to respond to Health Authority observations is preferred.
  • Knowledge of process design, development and continual improvement is desired
  • Knowledge of process improvement experience such as Six Sigma, Lean and Design Excellence is a plus.

Primary Location
United States-Pennsylvania-Spring House
Other Locations
North America, Europe/Middle East/Africa
Johnson & Johnson Services Inc. (6090)
Job Function
Compliance Security

Share this Job