Sr. Specialist, PQ

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

Location: Cherry Hill, New Jersey

Job Type:Full-Time

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.

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.

• 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.

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.

• 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

.

• Strong analytical and problem-solving skills with a risk-based approach to quality…