Quality Site Head / Quality Director

Nexus Search; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

Nexus Search partners with a major pharma manufacturer to appoint two Site Quality Heads for sterile injectable manufacturing sites in the US. Each role is the most senior quality leader on site, responsible for QA, QC and Quality Systems, leading FDA readiness and remediation, and embedding a quality culture to support growth.

The positions require proven sterile/aseptic quality leadership, extensive FDA inspection experience, and deep knowledge of cGMP, ISO 14644, contamination control, and

Qualifications

• Experience leading QA/QC at a sterile site.
• FDA inspections experience and close-out of 483/Warning Letters.

Responsibilities

• Own QA, QC, Microbiology, Validation support and Training.
• Lead FDA inspections and customer audits.
• Remediate and improve quality systems; manage CAPAs and deviations.
• Set aseptic practice standards and environmental monitoring.
• Own batch disposition authority.
• Drive supplier and materials quality.
• Build quality leadership bench and culture.
• Report to Site Head with dotted line to Global Head of Quality.

Skills

Quality leadership

Aseptic manufacturing

cGMP knowledge

Regulatory inspections

Job description

Nexus Search are partnered with a $B revenue Pharma manufacturer to appoint two Site Quality Heads for major sterile injectables manufacturing sites in the US. One site in the Midwest employs 600+ people, and the other with 200+ . Both are scaling on the back of sustained demand and investment.

Each role is the most senior quality leader on site, with full accountability for QA, QC and Quality Systems. The mandate is to strengthen and rebuild the quality function, lead FDA remediation and inspection readiness, and embed a quality culture that supports the site’s next phase of growth.

The role

• Full ownership of Quality at a sterile injectables site, across QA, QC, Microbiology, Validation support and Training
• Lead FDA inspections and customer audits as the site quality lead, including responses and follow-up
• Own remediation and continuous improvement of the quality system, with investigations, deviations, CAPAs and change controls closed robustly and on time
• Set and hold the standard for aseptic practice, contamination control and environmental monitoring
• Own batch disposition and the authority to release or reject product
• Drive supplier and materials quality, including container-closure performance
• Build the quality leadership bench and a culture of accountability as the site grows
• Report to the Site Head, with a dotted line to the Global Head of Quality

What you will bring

• Sterile injectables or aseptic manufacturing quality leadership; this is essential
• Current or recent experience as a Site Head of Quality or Quality Director, accountable for both QA and QC at a sterile site
• A strong FDA track record, including leading inspections and taking a 483 or Warning Letter through to close-out
• Deep knowledge of cGMP, ISO 14644, contamination control and aseptic process validation
• The presence to hold the line on quality while partnering closely with operations and commercial leaders