Sr. Director, Quality Compliance & Systems

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.