Incoming Inspections Lead

Location: Raleigh, NC (Onsite)
Salary: $80,000–$110,000

Position Summary

The Incoming Inspections Lead provides technical leadership and oversight for incoming inspection activities involving raw materials, components, and packaging materials to ensure compliance with cGMP, regulatory, and internal quality standards. This role serves as the Subject Matter Expert (SME) for incoming quality operations, partnering with Quality, Manufacturing, Procurement, Warehouse, Regulatory Affairs, and suppliers to ensure material quality, inspection readiness, and continuous improvement.

Key Responsibilities

• Lead and manage the incoming inspection program, ensuring all incoming materials meet quality specifications and regulatory requirements prior to release.
  

• Serve as the SME during FDA, EMA, and other regulatory inspections, including audit preparation and response activities.
  

• Provide technical leadership, coaching, mentoring, and training for incoming inspection analysts and technicians.
  

• Review and approve incoming inspection documentation, specifications, test methods, and analytical results.
  

• Ensure sampling and testing activities are performed in accordance with SOPs, cGMP, USP, and applicable compendial requirements.
  

• Develop and maintain sampling plans, material specifications, acceptance criteria, and testing procedures.
  

• Lead investigations involving nonconforming materials, OOS/OOT results, supplier quality issues, root cause analysis, and CAPA implementation.
  

• Support supplier quality activities, including material qualification, supplier audits, and change notifications.
  

• Manage lifecycle activities for incoming material specifications, including change control, periodic review, and continuous improvement.
  

• Ensure laboratory equipment and systems remain qualified, calibrated, maintained, and audit-ready.
  

• Maintain compliance with cGMP, USP, internal quality standards, and ALCOA+ data integrity requirements.
  

• Partner with QA, Manufacturing, Procurement, Warehouse, Regulatory Affairs, and Supply Chain to support timely material release and uninterrupted production.
  

• Drive continuous improvement initiatives to improve inspection efficiency, compliance, and operational effectiveness.
  

• Support audit readiness and participate in internal and external inspections.
  

• Promote safe laboratory and warehouse practices while identifying and escalating quality or safety concerns.
  

• Perform additional duties as assigned.

Required Qualifications

• Bachelor’s degree in Chemistry, Biology, or another scientific discipline with 5+ years of relevant experience, or an equivalent combination of education and experience.
  

• Strong background in incoming inspection, raw material testing, or Quality Control within a cGMP-regulated pharmaceutical or biotechnology environment.
  

• Working knowledge of cGMP regulations, USP requirements, material specifications, ANSI/ASQ or ISO sampling plans, and quality systems.
  

• Demonstrated experience leading investigations involving nonconforming materials, supplier quality issues, OOS/OOT events, and CAPA implementation.
  

• Strong leadership, critical thinking, problem-solving, and decision-making skills.
  

• Excellent written and verbal communication skills with the ability to collaborate across multiple departments and external suppliers.

Preferred Qualifications

• Experience with LIMS, ERP systems (SAP preferred), and ALCOA+ data integrity principles.
  

• Lean Six Sigma or continuous improvement experience, including risk-based sampling or process optimization.
  

• Previous lead or supervisory experience within Quality Control or Incoming Inspection.
  

• Experience supporting supplier audits, supplier performance management, and external quality partnerships.

Work Environment

• Onsite position located in Raleigh, NC.
  

• Laboratory and warehouse environment within a pharmaceutical manufacturing facility.
  

• PPE required in designated areas.
  

• Ability to stand, walk, and perform inspection activities for extended periods.
  

• Ability to lift up to 50–75 pounds as needed.
  

• Flexibility to support operational needs, including occasional extended hours or schedule adjustments.

Key Competencies

• Strong analytical and critical thinking abilities.
  

• High attention to detail and data accuracy.
  

• Ability to interpret material specifications, Certificates of Analysis (CoAs), and technical documentation.
  

• Excellent organizational and prioritization skills.
  

• Proven leadership and mentoring capabilities.
  

• Strong interpersonal and cross-functional communication skills.
  

• Ability to make sound, quality-focused decisions in a fast-paced cGMP environment.

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