Head of Quality

Head of Quality – Pharmaceutical CDMOLocation: New JerseyType: Full-time, PermanentIndustry: Pharmaceutical Manufacturing / CDMOAL 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.Key ResponsibilitiesLead the Quality function for a pharmaceutical manufacturing site in New JerseyManage, mentor, and develop a small Quality team of approximately 4–5 direct reportsAct as the site Quality lead during: Client audits, FDA inspections, DEA audits, State DOH inspections, Other regulatory inspectionsMaintain site-wide inspection readiness across Quality, Manufacturing, QC, Validation, and ComplianceOversee core Quality Systems, including:Deviations, CAPAs, Change controls, Investigations, Complaints, Batch record review, Supplier quality, Internal and external auditsPartner closely with Manufacturing, Technical Operations, Regulatory Affairs, Validation, QC, and senior leadershipSupport client-facing Quality discussions, audit responses, and follow-up actionsDrive continuous improvement across Quality Systems, GMP compliance, and operational readinessEnsure compliance with cGMP, FDA, DEA, State DOH, and internal Quality standardsRequirementsStrong Quality leadership experience within pharmaceutical manufacturingExperience in a CDMO, CMO, or client-facing pharmaceutical manufacturing environment is highly preferredProven experience supporting or leading audits/inspections from: FDA, DEA, State Department of Health, Client audit teams, Other regulatory bodiesStrong knowledge of cGMP and pharmaceutical Quality SystemsExperience with:, Deviation management, CAPA, Change control, Batch record review/release, Investigations, Audit readiness, Inspection preparationPrevious people management experienceComfortable managing a small team while remaining hands-on when requiredStrong communication skills with the confidence to represent the site externallyExperience in drug product manufacturing, sterile manufacturing, aseptic processing, or oral solid dose manufacturing would be advantageous