Senior Manager, Computerized Systems Quality Assurance

Sparc The World

  • USA
  • $140,000-155,000 per year
  • Permanent
  • Full-time
  • 27 days ago
Our client is a patient-centered, clinical-stage biopharmaceutical company committed to developing cell therapies for patients with autoimmune diseases. They leverage advanced T cell engineering to suppress and eliminate autoreactive immune cells, addressing the root cause of autoimmune and inflammatory diseases. By joining this pioneering team of scientists, industry veterans, and healthcare visionaries, you'll contribute to transforming the treatment landscape for autoimmune diseases.We are seeking a highly motivated Senior Manager of Computerized Systems Quality Assurance (CSQA) for our client's Quality organization. In this role, you will lead the development and implementation of a robust Software Quality Assurance (CSA) program, focusing on GAMP 5 and Health Authority compliance. Your responsibilities will include ensuring compliance for systems managed internally as well as assessing and communicating risks associated with systems managed by contract service providers (CSPs) and partners. Upholding regulatory requirements, enhancing quality compliance, and maintaining the highest standards of quality in CSA across technical, clinical, and regulatory operations will be central to your mission.Responsibilities:
  • Collaborate with cross-functional teams to support automation, document management, and learning management strategies for the organization's operations.
  • Develop and maintain the client's CSA program, including protocol establishment, lifecycle management, and CSP audit support.
  • Manage validation/qualification of systems as necessary to support clinical trials.
  • Provide expertise in investigating computerized system quality events.
  • Support the development and monitoring of key performance indicators and risk management processes.
  • Ensure timely resolution of computerized system issues and provide support for system administration.
  • Work with leadership to design, implement, and maintain appropriate levels of automation.
  • Support business development due diligence projects related to laboratory capabilities.
  • Perform other duties as assigned.
Requirements:
  • Bachelor's degree or higher in life sciences, computer sciences, or related field, or equivalent experience.
  • 8+ years of pharmaceutical manufacturing and/or Quality Assurance experience, with at least 2 years in computer systems validation.
  • Experience implementing systems compliant with GAMP 5, Annex 11, or Part 11.
  • Ability to manage contract resources supporting CSV.
  • Deep knowledge of lifecycle quality management, regulatory information, or ERP systems.
  • Strong critical thinking, troubleshooting, problem-solving, and risk assessment skills.
  • Strategic thinking and high emotional intelligence.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to work independently in a dynamic environment and manage multiple projects effectively.
  • Capacity to think creatively when addressing complex situations.
  • Effective communication with internal teams, external partners, and Regulatory Authorities.
Salary Range:The salary range for this position is from $140,000 - $155,000 USD annually. Actual salary may vary based on factors such as education, experience, skills, and internal equity.Equal Opportunity Employer:Our client is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all employees without regard to race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other legally protected status.

Sparc The World