Quality Systems Manager

POSITION: Quality Systems Manager

Responsibilities:
- Ensure compliance with applicable GxP systems, including document management (eDMS), training (LMS), and the electronic quality management system (eQMS).
- Manage GxP document control: creation, review, approval, revision, obsoletion, and storage of SOPs/work instructions/policies and records; may include QA review; maintain eDMS.
- Manage eQMS processes (deviations, change controls, audits, CAPAs, investigations, vendor management, complaints); evaluate system functionality and implement value-added features.
- Oversee GxP training: maintain compliant training for stakeholders, support training curricula/materials, track completion rates, and manage the training system.
- Serve as Corporate Training Coordinator and support corporate document management/training.
- Support regulatory inspections/audit requests (e.g., FDA, EMA); implement/maintain/report quality metrics and KPIs; prepare Quality Management Review materials.
- Partner cross-functionally (IT, CMC, Supply Chain, Clinical Ops/QA, Biometrics, Regulatory) to implement procedures and ensure quality compliance.

Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 3–5+ years in quality systems/QA and document/training management in biotech/pharma.
- Phase 3 clinical trials and transition to commercialization highly preferred.

Skills:
- Expertise in GxP, FDA/EMA/ICH requirements, documentation/compliance management; cross-functional collaboration; problem-solving/analytical skills; strong written/verbal communication; comfortable with remote fast-paced environments.

Comp/Benefits (as stated):
- Salary range: $170,000–$180,000/year.
- Health coverage, flexible PTO, parental leave, 401(k).