QA Compliance Specialist

Hikma Pharmaceuticals

Specialist, QA Compliance supporting regulatory compliance policies at Hikma Pharmaceuticals. Focused on quality assurance and continuous improvement in pharmaceutical manufacturing.

Posted 4/30/2026full-timeBedford • Ohio • 🇺🇸 United StatesMid-LevelSenior💰 $44,900 - $74,950 per yearWebsite

About the role

Key responsibilities & impact

Assist in implementing and overseeing systems relating to: CAPA, Change Control, Annual Product Review, GMP, Supplier Quality, Recalls, Field Alerts, Internal & External Auditing, Customer Complaints, 483 Gap Analysis, etc.
Assist with ensuring compliance with the FDA CFR, including cGMP and DEA regulations, as well as State Board of Pharmacy rules and regulations.
Monitor and communicate changes in regulations of all state and federal regulatory agencies.
Assist in collaborating on stability study protocols, Master Batch Records, and product specification requirements ensuring compliance with all company procedures and federal and state laws, rules, and regulations.
Support inspection readiness program
Oversee customer complaints and adverse drug reaction program.
Participate in product trend analysis, including owning the Annual Product Review program.
Perform periodic gap analyses on 483 observations and new regulatory guidance’s.
Assist in writing, review and update of batch records, SOPs, and other cGMP documents.
Manage execution of internal and external audits to assess and maintain compliance with regulatory and customer requirements.
Assist the Quality Group in response to regulatory requests and inspection audits.
Review, prepare, and/or approve all written responses to audits and inspections.
Oversee Supplier Quality program, including review and approval of Supplier Qualification & Performance documents (i.e., supplier audits, notifications, CAPAs, etc.).
Initiate, review, and/or approve Quality (and Technical) Agreements.
Participate in the preparation and execution of dashboard metrics evaluating key performance indicators for all departments.
Participate / execute Internal Audits as per Annual schedule, compile report, review CAPA responses.
Participate in the administration of Site Projects.
Assist in the development and provision of GMP, Aseptic Behavior, and Quality Systems-related training to all applicable departments.
Provide technical support in the interactions with and applications to state and federal regulatory bodies.
Support for Documentation control activities (issuance of Batch Records, Logbooks, etc) as a backup.
Other duties, as assigned.

Requirements

What you’ll need

Bachelor of Science in Pharmacy, Chemistry, Microbiology, or other scientific disciplines.
Minimum: 3 – 5 years of pharmaceutical industry experience.
Preferred: Experience in Quality Systems and Compliance.
Knowledge of Injectables manufacturing process / practices.
Knowledge of associated standards and operating procedures in relation to cGMP.

Benefits

Comp & perks

Annual performance bonus, commission, and share potential
Auto 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
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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

CAPAChange ControlAnnual Product ReviewGMPSupplier QualityInternal AuditingSOPsQuality AgreementsAseptic BehaviorQuality Systems

Soft Skills

collaborationcommunicationproblem-solvingattention to detailorganizational skillsinspection readinesstechnical supporttraining provisionreport compilationregulatory response

Certifications

Bachelor of Science in PharmacyBachelor of Science in ChemistryBachelor of Science in Microbiology