Position Summary
- Provide operational support enabling the Quality Assurance organization to execute efficiently and consistently.
- Coordinate business-critical QA activities across multiple concurrent priorities, managing Quality Systems, Document Control, and the Learning Management System (LMS) for GxP operations.
Essential Duties and Responsibilities
- Coordinate Quality Assurance activities for cross-functional projects, commercial partners, and GMP vendors to ensure timely business-critical deliverables.
- Develop, maintain, and continuously update the integrated QA workplan (priorities, milestones, resources, deliverables).
- Track priorities/action items/milestones; identify risks and drive completion.
- Participate in cross-functional meetings; document decisions/action items and monitor execution.
- Provide regular status updates to QA leadership and stakeholders.
- Own the shared QA mailbox for triage and coordination of Quality-related requests.
- Compile and report Quality metrics and KPIs.
Quality Systems & Document Control
- Administer Dot Compliance EDMS/EQMS (or equivalent): configuration, roles/permissions, document structures, system integrity.
- Manage controlled document lifecycle (creation through archival/obsolescence) per applicable GxP requirements.
- Maintain document integrity/accessibility; improve templates/formatting and document control processes.
- Support document authors/reviewers; apply advanced Microsoft Word skills to produce controlled documents.
Learning Management System
- Administer GxP LMS in Dot Compliance; develop curricula/assignments/assessments.
- Monitor compliance/completion, troubleshoot issues, and maintain current training requirements.
- Generate training effectiveness and regulatory compliance reports/metrics.
Knowledge and Skill Requirements
- Bachelorβs degree in a scientific/technical/related discipline.
- 6+ years in QA/Quality Systems/Document Control/Program Coordination or related GxP (pharma/biotech/life sciences).
- Working knowledge of cGMP, GLP and/or GCP.
- Experience with electronic document/quality systems (e.g., Dot Compliance, Veeva, MasterControl).
- LMS administration experience preferred.
- Advanced Microsoft Word skills.
- Strong organization, communication, and ability to manage competing priorities independently.
Compensation and Benefits
- Salary range: $140,000 to $170,000.
- Benefits: medical/dental/vision; life and disability; flexible spending accounts; paid time off and holidays; 401(k); other benefits.