Sr. Specialist, 3PQ

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

Job Title: Sr. Specialist, Quality – Third Party/CMO

Location: Cherry Hill, New Jersey

Job Type:Full-Time

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Specialist, Quality to join our team. In this role, you will be responsible for ensuring that products manufactured by third-party Contract Manufacturing Organizations (CMOs) meet all applicable cGMP, regulatory, and Hikma quality requirements, serving as the primary quality liaison between Hikma and its external manufacturing partners for injectable products. Is responsible to release the products to US market.

Key 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 (FDA, EMA, and other health authorities).
• 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 (e.g., deviation trends, OOS/OOT rates, complaint rates, on-time release) 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 and release activities.
• Support regulatory inspections related to 3rd Party CMO operations, working closed with Corporate Compliance.

Qualifications:

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Bachelor’s degree in a relevant scientific, engineering, or technical discipline (e.g., Chemistry, Microbiology, Pharmacy, Engineering) required; advanced degree a plus.

EXPERIENCE:

• Minimum 4–6 years of experience in Quality Assurance/Quality Operations within the pharmaceutical industry, with direct experience in sterile/injectable manufacturing strongly preferred.
• Demonstrated 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).
• Experience with batch record review, CoC, CoAs, deviation/CAPA management, and change control systems.
• Audit experience (conducting and/or hosting), preferred

.

SKILLS:

• Strong analytical and problem-solving skills with a risk-based approach to quality decision-making.
• Excellent written and verbal communication skills; ability to influence cross-functionally and with external partners.
• Strong project management skills with the ability to manage multiple priorities.
• Proficiency with quality management systems (QMS) and metrics/reporting tools.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.