Senior Quality Specialist – 3rd Party CMOs (Injectables)

Hikma Pharmaceuticals; Cherry Hill Township (NJ); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

401(k) matching

PTO 20 days

Parental/maternity leave

Health/dental/vision

Employee discount

Job summary

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ, is seeking a Sr. Specialist, Quality – Third Party/CMO to ensure injectable products meet cGMP and regulatory requirements. You will act as the primary quality liaison with external CMOs and support product release.

The role requires 4–6 years in QA/Quality Ops within pharma, with CMO oversight experience. Strong knowledge of FDA, EU GMP, ICH, and QMS tools is essential.

Qualifications

• Bachelor’s degree in a relevant scientific, engineering, or technical discipline; advanced degree a plus.
• 4–6 years in Quality Assurance/Quality Operations within pharma, sterile/injectable preferred.
• Experience overseeing CMOs/external manufacturing partners; familiarity with FDA/EU GMP/ICH standards.

Responsibilities

• Serve as quality point of contact for assigned 3rd Party CMOs (manufacturing, packaging, testing).
• Review/approve CoC, CoA, batch records, deviations, CAPAs, change controls, investigations for compliance.
• Support product release by ensuring third-party documentation is complete and compliant.
• Maintain Quality Agreements with CMOs, defining roles and quality expectations.
• Lead or participate in CMO audits and ensure timely closure of observations and CAPAs.
• Monitor KPI metrics (deviations, OOS/OOT, complaint rates, on-time release) and elevate risks.
• Collaborate with Supply Chain, Regulatory Affairs, Manufacturing, and Quality to support lifecycle changes and releases.
• Support regulatory inspections related to CMO operations with Corporate Compliance.

Skills

Quality Assurance

CMO oversight

FDA Regulations

cGMP

Audit Management

Cross-functional collaboration

Education

Bachelor’s degree in a relevant scientific field

Tools

QMS Software

Job description

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ, is seeking a Sr. Specialist, Quality – Third Party/CMO to ensure injectable products meet cGMP and regulatory requirements. You will act as the primary quality liaison with external CMOs and support product release.

The role requires 4–6 years in QA/Quality Ops within pharma, with CMO oversight experience. Strong knowledge of FDA, EU GMP, ICH, and QMS tools is essential.