Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities. Ensure that products are manufactured in compliance with cGMP guidelines, USP, and FDA requirements. Oversee batch record review, control and release, and the investigation process (CAPA) to ensure any discrepancies are investigated thoroughly and timely. Approve all Change Controls, manage batch record documents, and provide QA-related metrics to different levels of the organization. Collaborate with the compliance group during external audits. Direct and manage people and systems to assure product quality and ensure non-compliant situations are investigated.
ResponsibilitiesOversee staffing and organization of QA activities.Ensure compliance with cGMP guidelines, USP, and FDA requirements.Direct batch record review, control, and release processes.Manage the investigation process (CAPA) for discrepancies.Approve Change Controls and batch record documents.Provide QA-related metrics to the organization.Collaborate during external audits.Direct and manage systems to assure product quality.Investigate non-compliant situations.Essential Skills3+ years in pharmaceutical quality assurance (injectables, vaccines, biologics, or small molecule).3+ years of QA experience.Experience with GMP, FDA, ISO, and USP.Proficient in batch record review, SOPs, and other technical documentation.2-3+ years in a supervisory or managerial role.Additional Skills & QualificationsExperience in sterile manufacturing and handling injectables.Work EnvironmentThe role includes managing four direct reports, including shift supervisors and a batch record lead. The majority of time will be spent in the quality office, but the candidate must be comfortable with hands-on tasks as necessary. The position offers a comprehensive benefits package, including performance bonuses, a 401(k) program, generous PTO, health benefits, and more. There are opportunities for career advancement, tuition reimbursement, and a focus on safety and quality.
Job Type & LocationThis is a Permanent position based out of Cherry Hill, NJ.
Pay and BenefitsThe pay range for this position is $120000.00 - $140000.00/yr.
•\tAnnual performance bonus, commission, and share potential•\tAuto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute•\tA generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries•\t3 personal days (prorated based on hire date)•\t11 company paid holidays•\tComprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits•\tEmployee discount program•\tWellbeing rewards program•\tSafety and Quality is a top organizational priority•\tCareer advancement and growth opportunities•\tTuition reimbursement•\tPaid 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.
Workplace TypeThis is a fully onsite position in Cherry Hill,NJ.
Application DeadlineThis position is anticipated to close on Mar 5, 2026.
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