Senior QA Specialist, 3P CMO Injectables

Hikma Pharmaceuticals; Cherry Hill Township (NJ); On-site; USD 67,000 - 134,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

20 days PTO

3 personal days

11 company holidays

Health, dental, vision

Employee discount

Wellbeing rewards

Tuition reimbursement

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ, seeks a Sr. Specialist, 3PQCMO to ensure third-party CMOs meet cGMP and regulatory requirements and to lead quality liaison activities for injectable products released to the US market.

The role emphasizes collaboration across Supply Chain, Regulatory Affairs, Manufacturing, and Quality Operations. The successful candidate will review CoCs, CoAs, batch records, deviations, CAPAs, and change controls; participate in audits; and drive timely

Qualifications

• Bachelor’s degree in a relevant scientific, engineering, or technical discipline.
• 4–6 years of Quality Assurance/Quality Operations experience in the pharmaceutical industry.
• Experience overseeing Contract Manufacturing Organizations (CMOs) or external manufacturing partners.
• Strong working knowledge of cGMP, FDA regulations, and international quality standards (EU GMP, ICH guidelines).
• Audit experience (conducting and/or hosting) is preferred.

Responsibilities

• Serve as the quality point of contact for assigned 3rd Party CMO(s), overseeing day-to-day quality activities related to manufacturing, packaging, and testing of injectable products.
• Review and approve 3rd Party CMO CoC, CoA, batch records, deviations, CAPAs, change controls, and investigations to ensure compliance with cGMP and applicable regulatory requirements.
• Support product release activities by ensuring 3rd Party CMO documentation is complete, accurate, and compliant prior to disposition.
• Support and maintain Quality Agreements with 3rd Party CMOs, ensuring roles, responsibilities, and quality expectations are clearly defined.
• Lead or participate in 3rd Party CMO audits (routine, for-cause, pre-approval) and drive timely closure of audit observations and CAPAs.
• Monitor 3rd Party CMO quality performance through KPIs and metrics and elevate risks as needed.
• Partner cross-functionally with Supply Chain, Regulatory Affairs, Manufacturing, and Quality Operations internally to support lifecycle changes at 3rd Party CMO sites.
• Support regulatory inspections related to 3rd Party CMO operations.

Skills

Analytical skills

Communication

Project management

QMS experience

Education

Bachelor’s degree in a relevant scientific, engineering, or technical discipline

Job description

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ, seeks a Sr. Specialist, 3PQCMO to ensure third-party CMOs meet cGMP and regulatory requirements and to lead quality liaison activities for injectable products released to the US market.

The role emphasizes collaboration across Supply Chain, Regulatory Affairs, Manufacturing, and Quality Operations. The successful candidate will review CoCs, CoAs, batch records, deviations, CAPAs, and change controls; participate in audits; and drive timely