Specialist II, Quality Compliance

Quality Specialist II, Quality Compliance — Hybrid (on-site at least 3 days/week)

Responsibilities:
- Support vendor qualification, monitoring, and requalification (documentation reviews and risk assessments)
- Coordinate vendor and internal GCP audits per the annual audit plan
- Support audit logistics, scheduling, documentation management, agendas, and audit communications
- Assist with audit reports; track observations and monitor CAPAs through closure
- Maintain audit records, schedules, and metrics in Veeva QMS and other quality systems
- Participate in GCP audits as an audit team member and build auditing skills via training/mentorship
- Support vendor performance monitoring and key vendor quality metrics
- Support quality agreement development, revision, execution, and periodic review
- Participate in inspection readiness and continuous improvement initiatives for GCP compliance
- Assist with development/maintenance of quality metrics, reports, and dashboards
- Identify process improvement opportunities and support quality/compliance initiatives
- Maintain awareness of evolving GCP regulations, guidance, and best practices

Qualifications (Preferred/Required):
- Excellent in Microsoft Office (Word, Excel, PowerPoint) required
- Basic understanding of GCP and best industry practices
- BA/BS in biological sciences, pharmacy, or related field required
- 2–4 years’ experience in clinical-stage pharmaceutical companies or related field

Travel:
- Up to 25% following certification as an auditor

Compensation:
- Pay range: $90,000–$115,000 (role is headquarters-based)

Application instructions:
- Applicants must be authorized to work in the United States full-time.