Quality Management Systems Manager

OpenKrill; United States; On-site; USD 109,000 - 129,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Leadership

Problem Solving & RCA

Detail Oriented

Communication

Strategic Thinking

Education

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

Master's degree, PCQI or ASQ certification

Tools

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

ERP software

PLM/eQMS platforms

Filemaker

Smartsheet

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Location - Vista, CA - Hybrid or Remote

Salary - 109K - 129K

POSITION SUMMARY

The Quality Management Systems (QMS) Manager is responsible for overseeing, standardizing, and advancing Nordic Naturals' quality management systems across headquarters and manufacturing facilities (Watsonville and Vista). Reporting directly to the Director of Quality, this role spearheads the development and implementation of an integrated electronic Quality Management System (eQMS). The QMS Manager oversees core compliance functions—including Document Control, Change Control, Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), Deviations, and Internal/External Quality Audits - ensuring rigorous cGMP compliance under 21 CFR Part 111 and 21 CFR Part 11 while driving a culture of continuous quality improvement.

Reasonable Accommodations Statement

To accomplish this job successfully, this individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.

ESSENTIAL FUNCTIONS

• eQMS Implementation & Governance: Lead the evaluation, integration, and administrative oversight of a unified electronic Quality Management System (eQMS) bridging multi-site operations (HQ, Vista, and warehouse locations).
• Document & Change Control Management: Oversee the Document Control team and manage Change Control (CCO/CCR) processes to ensure all Standard Operating Procedures (SOPs), Master Formulas, and Packaging Specifications strictly adhere to cGMP standards.
• CAPA & Non-Conformance Oversight: Direct cross-functional Non-Conformance Report (NCR) and Corrective and Preventive Action (CAPA) investigations and execution through an eQMS or other existing forums, ensuring timely execution of investigation and implementation steps.
• Audit Program Leadership: Manage the internal cGMP audit schedule across production, compounding, packaging, and laboratory areas. May need to be present for as a quality contact during FDA, NSF, and third-party regulatory audits.
• Cross-Functional Collaboration: Partner closely with Manufacturing, Operations, Product Development, and Technical Engineering teams to streamline quality workflows, eliminate production bottlenecks, and support new product launches and plant trials.
• Metrics & Quality Reporting: Establish, track, and report key quality performance indicators (KPIs) and monthly metrics (investigation cycle times, CAPA resolution rates, SOP gap closures) to the Director of Quality and leadership.
• Team Leadership & Development: Supervise, mentor, and evaluate direct reports within Quality Systems and Document Control, establishing clear accountabilities and professional development pathways.

POSITION QUALIFICATIONS

Competency Statements

• Leadership: Ability to influence cross-functional teams, drive accountability, and foster a collaborative, compliance-minded quality culture.
• Problem Solving & RCA: Advanced analytical capabilities in root cause investigation (RCA) and risk mitigation (FMEA, HACCP).
• Detail Oriented: Exceptional precision in evaluating complex documentation, batch records, investigations, and regulatory standards.
• Communication: Outstanding written and verbal communication skills for presenting quality findings and leading regulatory audit defense.
• Strategic Thinking: Ability to align QMS objectives with long-term corporate growth and operational scale.

SKILLS & ABILITIES

Education:

• Bachelor's degree in chemistry, Biology, Bioengineering, Quality Systems, or related scientific discipline required.
• Master's degree, PCQI or ASQ certification preferred.

Experience:

• 5+ years of direct experience in Quality Assurance or Quality Engineering within a cGMP dietary supplement, food, or pharmaceutical manufacturing environment, with 3+ years in a supervisory/management capacity.

Computer Skills:

• High proficiency with Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) software (e.g., SAP).
• Working knowledge with PLM/eQMS software platforms, Filemaker, Smartsheet.
• Advanced knowledge of Microsoft Office Suite (particularly Excel for data tracking, Word for SOP drafting, and PowerPoint for training delivery).