Job Title: Quality Assurance Manager
Location: Remote
Job Summary: We are seeking a skilled professional to drive the quality system processes for computerized system validation and risk-based validation programs. Our team values proactive engagement, operational excellence, and collaborative communication to ensure ongoing regulatory compliance and support continuous improvement.
Responsibilities:
- Serve as the primary Quality Assurance contact for change control initiatives related to computerized system activities.
- Review and approve validation deliverables such as validation plans, requirements assessments, testing protocols, and summary reports.
- Act as a change agent and advocate for the Risk Based Validation program while supporting process improvements and project initiatives.
- Review and approve Standard Operating Procedures (SOPs), as well as associated documents and periodic reviews for GxP systems.
Required:
- Experience in regulated industries, with strong background in computer systems validation and change control within GxP environments (GMP, GLP, GCP, GPvP).
- Demonstrated ability to interpret and apply regulatory guidelines with excellent organizational and communication skills.
- Experience initiating and collaborating with cross-functional teams, independently managing assignments, and handling escalations or conflict professionally.
- Master's degree in a technical or related subject with 3 years of directly relevant experience, or Bachelor’s degree with 5 years’ experience, or significant relevant experience in lieu of degree requirements.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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