Title: Senior Quality Associate, Computer Systems Compliance
Location: Raleigh, NC
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
The Senior Quality Associate, Computer Systems Compliance is responsible for supporting computer system validation and IT Compliance. The role is responsible for reviewing computer system validation documentation for assigned projects to ensure compliance with applicable process and regulatory requirements and for supporting other computer system compliance activities, such as periodic reviews. Specific assignments and activities will vary based on the priorities, needs and project deliverables of the Quality team. This position reports to the Sr. Manager, Computer Systems Compliance in Raleigh, NC. Minimal travel to other TG offices or suppliers is expected.
––Review computer system validation documentation for process and regulatory compliance
––Coordinate system compliance activities, such as system periodic reviews and system access reviews
––Assist in performing software/IT supplier audits and assessments.
––Support the investigation and documentation of applicable computer systems quality/data integrity/security incidents/issues as necessary.
––Support the collection and reporting of quality metrics.
––Support various data quality projects.
– Serve as the disease area expert and providing support to cross functional team members, including onboarding and review of materials
––3+ years of experience in computer system validation and/or IT Quality Assurance in a Clinical and/or GMP setting. Experience associated with Outsourced IT systems, Software as a Service, and Quality Systems development, preferred.
––Working knowledge of regulations for electronic systems validation and data integrity (e.g., 21CFRPart 11, EU Annex 11, FDA/PICS Data Integrity Guidance)
––Must have excellent attention to detail, time management and investigative skills, as well as ability to manage multiple priorities with aggressive timelines.
––Must have strong written and oral communication skills
––Able to influence and work within a team environment.
––In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
Can travel domestically and internationally approximately 25% of the time (post-pandemic).
• Willingness and ability to travel domestically and internationally, as required.
Bachelor’s degree, or higher, in life sciences or related fields