Associate Director, Laboratory Quality Operations

X4 Engineering; North Carolina; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive salary plus benefits

A senior role with real influence,背 by

Fully on-site, Monday to Friday, 8am –

Job summary

X4 Engineering in North Carolina is seeking an experienced head of site quality to lead a team ensuring cGMP compliance and regulatory readiness. You will own the QA program, drive continuous improvement, and interact with regulators and clients to maintain the highest quality standards.

This senior role requires a chemistry/biology/microbiology background, 10+ years in pharma quality, and proven people leadership.

Qualifications

• Degree in Chemistry, Biology or Microbiology is required.
• 10+ years in pharma quality, including at least 7 leading people.
• Expert cGMP knowledge with hands-on experience in QMS, CAPA and data integrity.

Responsibilities

• Lead, coach and grow the site Quality team.
• Own the site’s compliance with SOPs, cGMP and FDA standards.
• Lead regulatory inspections and client audits.
• Set quality goals and build the internal audit programme.

Skills

People leadership

Quality management

cGMP knowledge

QMS

CAPA

Data integrity

Root-cause analysis

Clear writing

Education

Degree in Chemistry/Biology/Microbiology

Job description

Ready to run a site’s quality function and shape how it grows? You’d lead a team whose work helps new medicines reach patients.

The company

They support pharma and biotech clients from early development to commercial supply. Clients choose them for their strong record with regulators, so quality is valued here and never treated as an afterthought.

The role

• Lead, coach and grow the site Quality team
• Own the site’s compliance with SOPs, cGMP and FDA standards
• Lead regulatory inspections and client audits
• Set quality goals and build the internal audit programme

What you’ll need

• A degree in Chemistry, Biology or Microbiology
• 10+ years in pharma quality, including at least 7 leading people
• Expert cGMP knowledge, plus hands-on experience with QMS, CAPA and data integrity
• Strong root-cause analysis and clear writing

What’s on offer

• Competitive salary plus benefits
• A senior role with real influence, backed by the corporate quality team
• Fully on-site, Monday to Friday, 8am to 5pm, with no weekends
• Up to 10% travel, mostly between local sites (driving licence needed)