QA Document Control & Training Leader

Regulatory Toolkit

Greenville (NC)

Sur place

USD 120 000 - 160 000

Plein temps

14 jours+

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Résumé du poste

Thermo Fisher Scientific is seeking a Manager of QA Document Control & Training Compliance to lead governance for GMP document control, records management, LMS, and training across a large sterile injectable manufacturing operation.

You will own the eDMS/LMS, drive continuous improvement, and partner across Manufacturing, Quality Control, Engineering, and Operations to ensure inspection readiness and data integrity throughout document lifecycles.

Qualifications

Bachelor's degree required; Master's preferred.
Minimum 6 years in pharmaceutical/biopharma manufacturing, with 3+ in leadership or people management.
Experience with GMP document lifecycle and electronic systems.
Familiarity with FDA 21 CFR Parts 210/211 and data integrity principles.

Responsabilités

Lead the Document Control and Training Compliance team; set objectives and drive continuous improvement.
Act as site owner for eDMS and LMS; manage governance, access, workflows, and data integrity.
Own governance for controlled documents, training administration, curricula, and qualification records.
Partner cross-functionally to identify compliance risks, implement CAPAs, and improve QMS effectiveness.
Ensure records and training meet cGMP, GDP, and regulatory requirements.
Provide readiness for inspections and regulatory audits with timely evidence retrieval.