Senior Manager, Computerized Systems Quality Assurance
Sparc The World
- USA
- $140,000-155,000 per year
- Permanent
- Full-time
- 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.
- 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.