Remote Senior Director, Quality Compliance & Systems

MeridianMade; United States; Remote; USD 180,000 - 260,000; Full time

Job summary

MeridianMade, a domestic manufacturing and innovation platform, seeks a Senior Director of Quality Compliance & Systems to ensure products meet the highest standards and regulatory expectations. This remote role offers the option to work from a facility or NYC office and leads the Quality Compliance and Quality Systems strategy.

You will guide CFRs, FSMA, CGMPs for infant formula, manage FDA and customer audits, and drive digital traceability by owning LIMS, QMS, and ERP quality modules across

Qualifications

• 10+ years of regulatory compliance leadership in food, pharmaceutical, or infant-nutrition manufacturing.
• Direct experience with powdered infant-formula production, including process controls and regulatory requirements.
• Proven success engaging with regulatory agencies, including FDA inspections and regulatory submissions.
• Strong leadership and interpersonal skills to guide cross-functional teams.
• Wamiliarity with quality-management systems and data integrity expectations.

Responsibilities

• Lead the Compliance & Quality Systems organization across development, manufacturing, distribution, and TPM operations.
• Ensure full compliance with CFRs, FSMA, CGMPs, and all infant-formula-specific regulatory requirements.
• Maintain readiness for FDA and customer audits across all facilities and serve as primary interface during inspections; ensure timely closure of 483s and commitments.
• Lead design, implementation, and validation of strategic QMS improvements including digital systems and CSV activities.
• Oversee deviations, product complaints, adverse events, and recall readiness; integrate quality systems into product development with R&D and Operations.

Skills

Regulatory leadership

Quality systems

FDA inspections

Cross-functional leadership

Risk management

Education

Bachelor's degree + advanced degree preferred

Tools

LIMS

SAP QM

Job description

MeridianMade, a domestic manufacturing and innovation platform, seeks a Senior Director of Quality Compliance & Systems to ensure products meet the highest standards and regulatory expectations. This remote role offers the option to work from a facility or NYC office and leads the Quality Compliance and Quality Systems strategy.

You will guide CFRs, FSMA, CGMPs for infant formula, manage FDA and customer audits, and drive digital traceability by owning LIMS, QMS, and ERP quality modules across