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Associate Director - Quality Systems, Regulatory & Compliance

RX2 Solutions

TITLE: Associate Director - Quality Systems, Regulatory & Compliance
TYPE: Direct Hire
LOCATION: East Windsor, NJ
ONSITE/REMOTE/HYBRID: Onsite with regular travel to Asbury Park, NJ
START DATE: May/June 2026

We are seeking an Associate Director, Quality Systems, Regulatory & Compliance to lead the execution and ongoing enhancement of quality systems, food safety programs, and regulatory compliance across designated manufacturing sites. This role is responsible for ensuring that products consistently meet internal standards, regulatory requirements, and customer expectations while promoting a culture of accountability, consistency, and audit readiness.

MAIN RESPONSIBILITIES
  • Develop and implement risk-based audit schedules aligned with regulatory and certification requirements.
  • Maintain and enhance SOPs, work instructions, and quality system documentation.
  • Support the implementation and ongoing compliance with GMP, HACCP, FSMA, and other regulatory standards.
  • Manage the internal audit program, including planning, execution, reporting, and verification of corrective actions.
  • Drive audit readiness and ensure timely resolution of audit findings.
  • Support external, customer, and regulatory audits and inspections.
  • Lead the execution and continuous improvement of food safety, quality systems, programs, and compliance processes across assigned locations.
  • Lead investigations related to nonconformances, customer complaints, and audit observations.
  • Conduct root cause analysis and oversee CAPA implementation, tracking, and effectiveness.
  • Analyze trends and collaborate cross-functionally to implement practical, risk-based improvements.
  • Ensure all documentation, inspections, and testing records are accurate, complete, and audit-ready.
  • Communicate quality performance, compliance status, and audit readiness to site and senior leadership.
  • Support product hold, release, traceability, and recall readiness activities.
  • Assist with supplier qualification and monitoring in partnership with Procurement and Technical teams.
  • Review internal and external testing results as needed.
  • Oversee complaint management processes, including investigation, trending, and corrective actions.
  • Lead, coach, and develop quality team members across assigned sites.
  • Partner with Operations and other functional teams to ensure effective execution of quality and compliance initiatives.
QUALIFICATIONS
  • Bachelor's degree in Food Science, Microbiology, Chemistry, Biology, or a related scientific discipline
  • 3-5+ years of leadership experience managing quality or food safety teams
  • 7-10+ years of experience in quality, food safety, regulatory, or compliance roles within a regulated manufacturing environment
  • Strong knowledge of HACCP, FSMA, FDA regulations, and GMP-based systems
  • HACCP certification (or ability to obtain within a specified timeframe)
  • Demonstrated ability to lead cross-functional initiatives and drive execution in a manufacturing environment
  • Experience with internal audits, external audits, regulatory inspections, CAPA systems, and root cause analysis
  • Strong communication, organizational, and problem-solving skills
  • Familiarity with ERP systems, QMS platforms, or document control systems is preferred
  • Experience supporting or leading GFSI certification programs (e.g., SQF, BRCGS, or equivalent) is a plus
  • Experience in multi-site manufacturing environments is a plus
  • PCQI certification is preferred
EOE STATEMENT
We are an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.
Vacancy posted 4 days ago
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