Quality Lead, Third-Party Injectables & CMO Oversight

RXinsider LTD.; Cherry Hill Township (NJ); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

PTO 20 days

Personal days

11 holidays

Health, dental, vision

Employee discounts

Wellbeing rewards

Career advancement

Tuition reimbursement

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Specialist, Quality to oversee quality activities for third-party CMOs manufacturing injectable products in US markets.

You will ensure cGMP compliance, review critical documentation, and support regulatory inspections while partnering with cross-functional teams to maintain product quality and timely releases. The role requires 4–6 years in pharma quality operations, experience with CMOs, and strong knowledge of FDA/EU guidelines.

Qualifications

• Bachelor’s degree in a scientific, engineering, or technical discipline; advanced degree a plus.

Responsibilities

• Serve as quality liaison for 3rd party CMOs in manufacturing, packaging, and testing of injectables.
• Review CoCs, CoAs, batch records, deviations, CAPAs, change controls, and investigations for regulatory compliance.
• Support product release activities ensuring documentation is complete and compliant before disposition.

Skills

Analytical thinking

Communication

Project management

Quality decision-making

Education

Bachelor's degree in a relevant scientific/technical discipline

Tools

QMS

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Specialist, Quality to oversee quality activities for third-party CMOs manufacturing injectable products in US markets.

You will ensure cGMP compliance, review critical documentation, and support regulatory inspections while partnering with cross-functional teams to maintain product quality and timely releases. The role requires 4–6 years in pharma quality operations, experience with CMOs, and strong knowledge of FDA/EU guidelines.