Marketing/communications - Advertising Manager Ii

Job Description Job Description: Job Description for Quality Consultant – M&A Due Diligence(Quality - QMS, QA/QC, HACCP & Food Safety)Location: United States (Remote/On-site as required/remote with travel as needed)Department: Quality / Regulatory AffairsReports To: Director of Quality or VP of M&A IntegrationJob Summary:We are seeking a seasoned and detail-oriented Quality Consultant with deep expertise in Quality Management Systems (QMS), Quality Assurance (QA), Quality Control (QC), HACCP and Food Safety to lead and support strategic Mergers & Acquisitions (M&A) due diligence efforts within the dietary supplement and nutraceuticals industry.This critical role will focus on evaluating the quality framework and regulatory compliance of target companies, identifying compliance gaps, operational risks, and regulatory alignment issuesensuring alignment with FDA regulations (21 CFR Part 111, 101), DSHEA, and internal corporate quality standards. The successful candidate will provide expert guidance on integration strategies to ensure seamless transition, sustained product quality, and operational continuity postacquisition.Key Responsibilities:A. M&A Due Diligence, QA Compliance and Strategic Support▪ Lead comprehensive quality assessments of target companies during M&A due diligence, including site audits, documentation reviews, and risk analysis.▪ Evaluate compliance with FDA 21 CFR Part 111 (cGMP), 21 CFR Part 101 (Labeling), DSHEA, GRAS and NDI dossiers▪ Identify and assess Regulatory red flags (e.g., warning letters, recalls), Structural/function claims, Ingredient traceability, Operational gaps▪ Review QMS, GMP compliance, HACCP plans, audit histories, regulatory filings, and regulatory certifications of target companies.▪ Identify gaps in quality systems and compliance risks and provide actionable mitigation recommendations for integration planning.▪ Collaborate with cross-functional teams (Legal, Regulatory, Operations, R&D) to ensure quality risks are accurately represented in deal evaluations.B. Quality Management Systems (QMS) Evaluation & Post-M&A Integration▪ Evaluate the robustness and scalability of existing QMS frameworks.▪ Assess and align the QMS framework of acquired entities with corporate standards and industry best practices such as ISO 9001, ISO 22000, FSSC 22000, ISO 14000 across the following pillars (Evaluate and harmonize):o Quality policies, manuals, SOPso Internal audit programso CAPA systems (root cause analysis, tracking, closure)o Deviation and change control processeso Training matrices and competency assessmentso Document and record control systemso Product and process validation protocolso Supplier qualification and vendor auditso Complaint handling and recall procedureso Risk management frameworkso Continuous improvement initiativeso Quality metrics (e.g., Right First Time, CAPA cycle time)▪ Ensure traceability and data integrity across production and quality records.C. Quality Assurance (QA), Quality Control (QC), HACCP & Food Safety Programs▪ Review and validate QA protocols (policies and procedures) including Batch release protocols, Deviation handling procedures, Product recall systems, Complaint investigation workflows.▪ Analyze historical quality metrics, audit reports, and customer complaint trends to assess systemic issues or risks.▪ Validate compliance with internal policies to ensure alignment with US FDA regulations, EU and international standards where applicable.▪ Evaluate laboratory practices, testing protocols (including microbiological and chemical analyses), and analytical methods used for raw materials, in-process and finished products.▪ Review heavy metal screening, and allergen control procedures.▪ Evaluate equipment calibration, validation, and maintenance programs.▪ Review HACCP plans and food safety programs for compliance with FDA or other appliable standards.▪ Assess Hazard analysis, Critical control points (CCPs), and Preventive controls. Assess risk controls for Biological, Chemical, and Physical hazards in manufacturing processes.▪ Validate Sanitation, Allergen and Pest control, and Environmental monitoring programs.D. Data Integrity, Audit Readiness, Reporting & Advisory▪ Ensure systems comply with FDA principles: Audit trail capabilities in ERP, LIMS, QMS tools, Electronic record handling, Signature controls, Backup and restricted access protocols▪ Design and execute audit qualification checklists to assess compliance maturity and identify critical and major gaps.▪ Prepare comprehensive audit reports, post site visits or document reviews, summarizing observations, risk ratings, and areas of concern.▪ Recommend risk-based CAPA plans with clearly defined root cause analysis, corrective/preventive strategies, and timelines.▪ Ensure all audit findings are closed in a timely manner with compliance verification and effectiveness checks.▪ Prepare detailed due diligence reports summarizing findings with Risk ratings, Observations, Recommendations and Mitigation strategies.▪ Advise senior leadership on quality-related deal risks and integration planning.▪ Support post-acquisition integration efforts as needed, including harmonization of quality systems.Qualifications:▪ Bachelor’s or Master’s degree in Food Science, Chemistry, Life Sciences, or related field.▪ Minimum 10 years of experience in Quality (QMS, QA/QC, HACCP and Food Safety) roles within the Dietary supplement, Nutraceuticals or Food Industry.▪ Preferred Certifications: Certified Quality Auditor (CQA), Certified HACCP Auditor (CHA), ASQ Certified Manager of Quality /Organizational Excellence (CMQ/OE)▪ Proven experience in M&A due diligence or integration projects is highly preferred.▪ In-depth knowledge of FDA regulations, DSHEA, GMP, HACCP, FSSC 22000, ISO 14000 and ISO 9001▪ Familiarity with FDA inspection trends, Import alerts, Regulatory warning letters▪ Ability to travel for on-site assessments, site audits and integration support.Soft Skills & Attributes:• Exceptional analytical and critical thinking skills.• Strong written, verbal communication abilities and stakeholder management skills.• Ability to work independently and manage multiple concurrent projects.• High attention to detail and commitment to regulatory integrity.• Collaborative mindset with cross-functional teams (Regulatory, Quality, R&D and Operations)Additional Sills: