Quality Systems Manager

Accountabilities:

• Own, implement, maintain, and continuously improve the corporate Quality Management System, establishing standardized processes, procedures, governance, and quality expectations across facilities.
• Provide guidance and support to facility Quality teams to ensure corporate requirements are consistently implemented while allowing for appropriate site-specific procedures.
• Manage the corporate Document Control program, including document creation, review, approval, issuance, revision, periodic review, archival, obsolescence, and controlled distribution.
• Lead the Change Control program, ensuring changes are documented, risk-assessed, reviewed, approved, implemented, communicated, and verified for effectiveness.
• Manage and support the Food Safety and Quality Training Program, including learning plans, training matrices, assignments, completion tracking, retraining requirements, and training records.
• Serve as the business owner and primary Quality administrator for Veeva QualityOne, supporting configuration, workflows, user adoption, data integrity, reporting, and continuous improvement.
• Develop, maintain, communicate, and support implementation of corporate Quality Standards, translating requirements into effective facility-level programs and procedures.
• Provide governance and workflow support for CAPAs, deviations, non-conformances, and OOS events, including investigation quality, root cause analysis, action planning, approvals, effectiveness checks, trending, and timely closure.
• Manage complaint trending and quality data analysis to identify recurring issues, emerging risks, systemic trends, and opportunities for corrective or preventive action.
• Support Management Reviews by compiling, analyzing, and presenting QMS performance indicators, CAPA and deviation status, complaint trends, audit observations, training performance, and other relevant quality metrics.
• Support internal, customer, regulatory, and certification audits by maintaining controlled, complete, current, and audit-ready QMS documentation and records.
• Partner with Quality, Operations, Product, Regulatory, Supply Chain, and other stakeholders to integrate quality requirements into business processes, new initiatives, and organizational changes.
• Monitor QMS effectiveness through metrics, trending, periodic reviews, and compliance assessments, recommending improvements based on risks, audit findings, recurring issues, and business needs.
• Provide training, coaching, and technical guidance to facility Quality teams and other stakeholders on QMS processes, documentation, QualityOne workflows, and applicable standards.
• Ensure corporate quality records are properly maintained, retained, protected, and readily retrievable in accordance with regulatory and company requirements.
• Drive harmonization and standardization across facilities while escalating significant compliance, product quality, or food safety risks to Quality leadership.

Requirements:

• Demonstrated experience implementing, managing, and improving Quality Management Systems in a regulated food, dietary supplement, consumer health, or related environment.
• 5+ years of Quality Systems or Quality Assurance experience with a bachelor’s degree in Food Science, Quality, Biology, Chemistry, Engineering, or a related field, or an equivalent combination of education and relevant technical experience.
• Working knowledge of applicable FDA requirements, including 21 CFR Part 111, and current Good Manufacturing Practices (cGMPs).
• Experience with document control, change control, training systems, CAPA, deviations, OOS investigations, complaint trending, and quality metrics.
• Experience administering electronic Quality Management Systems, with Veeva QualityOne strongly preferred.
• Knowledge of GFSI/SQF quality and food safety system requirements is preferred.
• Ability to develop corporate quality standards and effectively support their implementation across multiple facilities.
• Strong written and verbal communication, organization, analytical, problem-solving, and cross-functional collaboration skills.
• Ability to manage multiple priorities, drive timely closure of quality activities, and influence stakeholders without direct authority.
• Relevant certifications or formal training in quality systems, auditing, HACCP, SQF/GFSI, root cause analysis, or CAPA are preferred.
• Experience and training related to 21 CFR Part 111.
• Strong data-driven mindset with the ability to identify trends, assess risks, and translate quality information into actionable improvements.

Benefits:

• Base salary of $125,000–$140,000 plus bonus, depending on experience.
• Comprehensive benefits package designed to support employee and family well-being.
• Generous paid time off.
• Strong healthcare and benefits coverage for employees and their families.
• Wellness-focused perks and access to company products.
• Fully remote, high-trust work environment.
• Biannual company off-sites providing opportunities to connect with colleagues in person.
• Opportunity for significant ownership and career growth in a quality leadership role.
• Opportunity to work cross-functionally across Quality, Operations, Product, Regulatory, and Supply Chain.
• Environment focused on high standards, ownership, urgent impact, and continuous improvement.