QMS Transformation Lead: eQMS & Compliance

Nordic Naturals; Vista (CA); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Nordic Naturals is seeking a QMS Manager to oversee and advance its quality management systems across headquarters and manufacturing facilities in Watsonville and Vista. You will drive an integrated eQMS, oversee document/change control, NCR/CAPA investigations, audits, and cross-functional quality improvements.

Ideal candidates have 5+ years in QA/Quality Engineering in cGMP settings, with 3+ years in supervision, and strong experience with SAP or PLM/eQMS.

Formación

• 5+ years in quality assurance or quality engineering in cGMP manufacturing, with 3+ years in supervision.
• Bachelor’s degree in chemistry, biology, bioengineering, or related quality discipline; Master/PCQI/ASQ preferred.
• Proven leadership and cross-functional collaboration across multiple sites.
• Strong familiarity with QMS/ERP systems (e.g., SAP) and PLM/eQMS platforms.

Responsabilidades

• Lead evaluation, integration, and governance of a unified eQMS across HQ and Vista facilities.
• Oversee Document Control and Change Control to ensure SOPs meet cGMP.
• Manage NCR and CAPA investigations and corrective actions.
• Lead internal and external audits, including FDA/NSF/regulatory audits.
• Collaborate with Manufacturing, Operations, Product Development, and Engineering.
• Establish and report KPIs and monthly quality metrics.
• Supervise and develop the quality systems and document control team.

Conocimientos

Leadership

Problem solving

Detail oriented

Communication

Strategic thinking

Educación

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

Master’s degree, PCQI or ASQ certification preferred

Herramientas

SAP

PLM/eQMS

Filemaker

Smartsheet

Excel

PowerPoint

Descripción del empleo

Nordic Naturals is seeking a QMS Manager to oversee and advance its quality management systems across headquarters and manufacturing facilities in Watsonville and Vista. You will drive an integrated eQMS, oversee document/change control, NCR/CAPA investigations, audits, and cross-functional quality improvements.

Ideal candidates have 5+ years in QA/Quality Engineering in cGMP settings, with 3+ years in supervision, and strong experience with SAP or PLM/eQMS.