Site Quality Head

Nexus Search; United States; On-site; USD 180,000 - 300,000; Full time

Job summary

Nexus Search is seeking a Site Head of Quality for a large sterile pharmaceutical manufacturing facility in the central United States. The role leads Quality Assurance, Quality Control, Microbiology, Environmental Monitoring, and Training for a 600+ person site.

The incoming leader will have full budget authority, a seat at the site leadership table, and a mandate to rebuild the function from the floor up, reporting to the site GM with a dotted line to corporate QA.

Qualifications

• Bachelor of Science or Bachelor of Pharmacy degree.
• 10+ years of progressive quality experience in sterile pharmaceutical manufacturing, including at least 5 years managing both QA and QC functions.
• Deep working knowledge of aseptic processing, sterile injectables, and cleanroom operations.
• Direct experience with FDA inspections, including leading the site through a 483 observation or similar regulatory action.
• Thorough command of FDA cGMP regulations (21 CFR Parts 210/211), USP chapters (797, 71), and ISO 14644.
• Track record managing quality organizations of 50+ people (direct and indirect).

Responsibilities

• Own disposition of incoming materials and finished product, including final release authority.
• Lead Quality Assurance operations: batch record review, deviation management, change control, CAPA, and complaint investigation.
• Oversee Quality Control laboratories including analytical testing, microbiological testing, environmental monitoring, and equipment calibration/validation.
• Build and maintain the site training program so that all personnel are current on department procedures, quality systems, and cGMP requirements.
• Manage regulatory inspections (FDA, state Board of Pharmacy) end to end: preparation, hosting, 483 response, and remediation follow through.
• Drive quality culture across the site with consistent floor presence and direct engagement with production, engineering, and operations leadership.
• Lead management review, compile site quality metrics and KPIs, and prepare periodic regulatory reports.
• Manage the quality budget including headcount planning, capital equipment, and project spend.
• Evaluate and implement new technologies, instrumentation, and processes that improve compliance and operational efficiency.
• Develop quality leaders within the organization through coaching, workload planning, and clear career progression.

Skills

Quality leadership

Regulatory knowledge

People management

Aseptic processing

FDA inspections

cGMP knowledge

Education

Bachelor of Science or Bachelor of Pharmacy

Job description

A growing sterile pharmaceutical manufacturer is looking for a Site Head of Quality to lead all quality functions at a large scale production facility in the central United States. The site employs 600+ people and produces sterile injectable products under FDA and state Board of Pharmacy oversight.

The quality organization is approximately 100 people spanning Quality Assurance, Quality Control, Microbiology, Environmental Monitoring, and Training. All report through this role.

This is not a maintenance assignment. The site has navigated a period of significant regulatory scrutiny and the executive team is investing in a quality culture transformation. The incoming leader will have a clear mandate, budget authority, and a seat at the site leadership table to rebuild the function from the floor up. Reports to the site General Manager with a dotted line to the corporate quality organization.

Key responsibilities

• Own disposition of incoming materials and finished product, including final release authority
• Lead Quality Assurance operations: batch record review, deviation management, change control, CAPA, and complaint investigation
• Oversee Quality Control laboratories including analytical testing, microbiological testing, environmental monitoring, and equipment calibration/validation
• Build and maintain the site training program so that all personnel are current on department procedures, quality systems, and cGMP requirements
• Manage regulatory inspections (FDA, state Board of Pharmacy) end to end: preparation, hosting, 483 response, and remediation follow through
• Drive quality culture across the site with consistent floor presence and direct engagement with production, engineering, and operations leadership
• Lead management review, compile site quality metrics and KPIs, and prepare periodic regulatory reports
• Manage the quality budget including headcount planning, capital equipment, and project spend
• Evaluate and implement new technologies, instrumentation, and processes that improve compliance and operational efficiency
• Develop quality leaders within the organization through coaching, workload planning, and clear career progression

Qualifications:

Required

• Bachelor of Science or Bachelor of Pharmacy degree
• 10+ years of progressive quality experience in sterile pharmaceutical manufacturing, including at least 5 years managing both QA and QC functions
• Deep working knowledge of aseptic processing, sterile injectables, and cleanroom operations
• Direct experience with FDA inspections, including leading the site through a 483 observation or similar regulatory action
• Thorough command of FDA cGMP regulations (21 CFR Parts 210/211), USP chapters (797, 71), and ISO 14644
• Track record managing quality organizations of 50+ people (direct and indirect)

Strongly preferred

• Advanced degree (MS, PharmD, or MBA)
• Experience at a facility that has undergone a warning letter, consent decree, or comparable remediation
• Familiarity with state Board of Pharmacy requirements in addition to federal FDA oversight
• Background in both human pharmaceutical and sterile compounding environments
• Experience standing up or rebuilding quality systems, not just maintaining inherited ones

Why this role

This is a mandate to fix, not a mandate to maintain. The organization has acknowledged where it fell short, committed the resources to correct it, and is looking for a leader who has done this before. The incoming Site Head of Quality will have genuine authority over the function, a direct line to the site GM, and the kind of visibility that only comes from a turnaround.

The position is on site, five days a week, in a US location with a relatively low cost of living.