Head of Quality

Industry: Pharmaceutical Manufacturing / CDMO

AL Solutions is supporting a growing pharmaceutical CDMO in New Jersey with the search for a Head of Quality to lead Quality operations at site level.

This is a key leadership role responsible for ensuring the site remains inspection-ready, compliant with GMP standards, and fully prepared for client and regulatory audits.

The successful candidate will be a hands‑on Quality leader who is confident representing the business in front of clients, the FDA, DEA, State Department of Health, and other regulatory bodies
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• Lead the Quality function for a pharmaceutical manufacturing site in New Jersey
• Manage, mentor, and develop a small Quality team of approximately 4–5 direct reports
• Act as the site Quality lead during:
  Client audits, FDA inspections, DEA audits, State DOH inspections, Other regulatory inspections
• Maintain site-wide inspection readiness across Quality, Manufacturing, QC, Validation, and Compliance
• Oversee core Quality Systems, including:

Deviations, CAPAs, Change controls, Investigations, Complaints, Batch record review, Supplier quality, Internal and external audits

• Partner closely with Manufacturing, Technical Operations, Regulatory Affairs, Validation, QC, and senior leadership
• Support client‑facing Quality discussions, audit responses, and follow‑up actions
• Drive continuous improvement across Quality Systems, GMP compliance, and operational readiness
• Ensure compliance with cGMP, FDA, DEA, State DOH, and internal Quality standards

• Strong Quality leadership experience within pharmaceutical manufacturing
• Experience in a CDMO, CMO, or client‑facing pharmaceutical manufacturing environment is highly preferred
• Proven experience supporting or leading audits/inspections from: FDA, DEA, State Department of Health, Client audit teams, Other regulatory bodies
• Strong knowledge of cGMP and pharmaceutical Quality Systems
• Experience with:, Deviation management, CAPA, Change control, Batch record review/release, Investigations, Audit readiness, Inspection preparation
• Comfortable managing a small team while remaining hands‑on when required
• Strong communication skills with the confidence to represent the site externally
• Experience in drug product manufacturing, sterile manufacturing, aseptic processing, or oral solid dose manufacturing would be advantageous