QMS Architect: Lead eQMS & Compliance (Hybrid/Remote)

Openkrill; United States; Hybride; USD 109 000 - 129 000; Plein temps

Résumé du poste

Nordic Naturals seeks a Quality Management Systems Manager to standardize and advance its QMS across headquarters and facilities, driving the development of an integrated eQMS and ensuring strict cGMP compliance under 21 CFR Part 111 and Part 11.

The role oversees document control, change control, NCRs, CAPA, deviations, and audits, directing cross-functional teams and reporting to the Director of Quality. Hybrid/remote options in CA with multiple sites.

Qualifications

• Bachelor degree in a scientific discipline with quality systems focus.
• Master PCQI or ASQ certification is preferred.
• 5+ years in Quality Assurance/Quality Engineering in cGMP environments.
• Experience leading cross-functional teams and audits.
• Strong knowledge of QMS, change control, CAPA, and deviations.

Responsabilités

• Lead evaluation, integration, and governance of a unified eQMS across sites.
• Oversee document control and change control processes ensuring SOPs and specs meet cGMP.
• Direct NCR and CAPA investigations with timely execution.
• Manage internal cGMP audits and support FDA/NSF/regulatory audits.
• Collaborate with Manufacturing, Operations, and Product Development to improve quality workflows.
• Track KPIs and report quality metrics to leadership.
• Supervise and mentor Quality Systems and Document Control staff.

Connaissances

Leadership

Problem Solving & RCA

Detail Oriented

Communication

Strategic Thinking

Formation

Bachelor's degree in chemistry, Biology, Bioengineering, Quality Systems, or related scientific discipline

Master's degree, PCQI or ASQ certification

Outils

Quality Management System (QMS) software (e.g., SAP)

ERP software

PLM/eQMS platforms

Filemaker

Smartsheet

Microsoft Excel

Microsoft Word

PowerPoint

Description du poste

Nordic Naturals seeks a Quality Management Systems Manager to standardize and advance its QMS across headquarters and facilities, driving the development of an integrated eQMS and ensuring strict cGMP compliance under 21 CFR Part 111 and Part 11.

The role oversees document control, change control, NCRs, CAPA, deviations, and audits, directing cross-functional teams and reporting to the Director of Quality. Hybrid/remote options in CA with multiple sites.