Job Title: Sr. Specialist, Quality – Third Party/CMO
Location: Cherry Hill, New Jersey
Job Type:Full-Time
Req ID: 12421
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 escalate 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)
- 11 company paid holidays
- Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
- Employee discount program
- Wellbeing rewards program
- Safety and Quality is a top organizational priority
- Career advancement and growth opportunities
- Tuition reimbursement
- 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.
Recruiters:
Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.
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.
