Sr. 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 is a domestic manufacturing and innovation platform helping quality-led functional nutrition brands go from formulation to finished goods.

Built on a decade-long investment in the platform now operating as MeridianMade — including three domestic facilities purpose-built to infant- and high-care manufacturing standards — our team brings 30+ years of functional protein manufacturing experience and deep expertise in regulated food innovation.

Our two core services: MeridianMade Manufacturing, our domestic contract manufacturing and packaging infrastructure, and MeridianMade Incubation, the science and go-to-market engine that takes brands from scientific concept to shelf-ready product. Together, they replace a fragmented vendor list with one accountable partner.

MANUFACTURING Three U.S. facilities, one integrated infrastructure covering high-care nutritionals and protein development: wet mixing and reaction, spray drying, dry blending, protein production, and packaging, including high-care stick packs. Our Reading, PA; Allerton, IA; and Portland, OR facilities are FDA-registered and built to infant formula-grade cGMP standards. Every engagement includes process optimization, supply chain, warehousing, logistics, and lab testing.

INCUBATION Capabilities span product development, formulation, medical affairs and clinical network, clinical strategy and evidence generation, claims development and substantiation, regulatory strategy, ingredient sourcing, manufacturing, go-to-market strategy, retailer and buyer relationships, and signal intelligence and quality management. One cross-functional team builds regulatory, science, and go-to-market planning in from day one.

BREADTH Our experience helps us serve brands across infant and toddler nutrition; functional proteins and ingredients (collagen, whey isolate, hydrolysates, caseinates); women’s health and adult nutrition (healthy aging, GLP-1 support, menopause); and medical nutrition.

ROLE DESCRIPTION

We're seeking a highly skilled Senior Director of Quality Compliance & Systems to ensure our products meet the highest standards and exceeds regulatory expectations. The position is remote with option to be at facility or NYC office, has the objective of providing strategic leadership in Quality Compliance and building best in class Quality Systems.

Reports To : Chief Quality Officer

Location : Remote

ROLES & RESPONSIBILITIES

• Lead the Compliance & Quality Systems organization for Meridian Made, covering 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, serve as the primary interface with FDA during inspections; ensure timely closure of 483s, commitments, and regulatory actions.
• Maintain deep understanding of the regulatory landscape, lead companywide proactive policy and strategy updates.
• Establish and maintain strong relationships with regulatory agencies, industry groups, and key opinion leaders.
• Responsible for the corporate Quality Management System (QMS), ensure alignment and harmonization across all sites.
• Lead design, implementation, and validation of strategic QMS improvements, including digital systems and CSV activities.
• Ensure compliant handling of deviations, product complaints, adverse events, and recall readiness.
• Integrate quality systems into product development processes in partnership with R&D and Operations.
• Own LIMS, QMS platforms, ERP/SAP quality modules, and digital traceability systems.
• Ensure systems meet FDA expectations for electronic records, audit trails, and data integrity.
• Drive modernization of compliance systems, automation, and digital traceability.
• Provide compliance oversight for process controls, CCP validation, sanitation, environmental monitoring, and allergen control.
• Oversee compliance risk assessments for equipment, facility changes, and capital projects.
• Ensure alignment with TPMs, laboratories, ingredient suppliers, and customers on compliance expectations.
• Lead the corporate Quality audit program: internal audits, supplier audits, TPM audits, and readiness assessments.
• Coordinate responses to regulatory inquiries and inspections, ensuring timely and accurate information flow.
• Own the enterprise compliance risk register for infant formula and TPM operations, develop and implement risk-assessment frameworks to proactively identify and mitigate risks.
• Lead crisis-management efforts related to regulatory or quality events, ensuring swift and compliant resolution.
• Partner with R&D, Regulatory Affairs, Supply Chain, Legal, Commercial, and Operations on product changes and new launches.
• Represent the company’s compliance position with FDA, Codex, industry associations, and external stakeholders.
• Develop and implement training programs to enhance regulatory and quality-system awareness across all departments
• Build leadership continuity through talent management, capability development, and succession planning.
• Drive a culture of proactive compliance, continuous improvement, and digital modernization.

Skills & Qualifications

• Bachelor’s degree in a relevant field required; advanced degree preferred.
• 10+ years of regulatory compliance leadership in food, pharmaceutical, or infant-nutrition manufacturing.
• Direct experience with powdered infant-formula production, including process controls, quality factors, and regulatory requirements.
• Technical background in aseptic processing and sterilization technologies preferred.
• Demonstrated success engaging with regulatory agencies, including FDA inspections, responses, and regulatory submissions.
• Proven ability to manage and influence suppliers, TPMs, consultants, and external partners to ensure compliance.
• Deep knowledge of U.S. and international regulations governing infant-formula production.
• Strong leadership and interpersonal skills, with the ability to guide and influence cross-functional teams.
• Exceptional analytical and problem-solving skills, with the ability to interpret complex regulatory requirements and develop practical solutions.
• Outstanding written and verbal communication skills, including the ability to brief senior executives and represent the company externally.
• Ability to present clear, actionable recommendations to the executive leadership team.
• High attention to detail and commitment to the highest standards of quality, safety, and data integrity.
• Ability to travel up to 30% to manufacturing sites, TPMs, regulatory meetings, and industry engagements.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.