Hikma Pharmaceuticals · 2 days ago
Manager, Quality Assurance
Cherry Hill, NJ
Full-time
Onsite
Mid, Senior Level
$93K/yr - $158K/yr
5+ years expHikma Pharmaceuticals is a leader in the pharmaceutical industry, and they are seeking a Manager of Quality Assurance. This role is responsible for overseeing QA monitoring of production activities to ensure compliance with regulatory guidelines and managing the batch review process to maintain product quality.
Health CareMedicalPharmaceutical
Responsibilities
Regular and predictable onsite attendance and punctuality
Directs the batch record review process. Makes final accept/reject disposition on product lots. Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner
Coordinates communication for status of lots and status of and resolves issues related to accept/reject disposition of batches
Places lots on HOLD if Quality issues are detected and notifies senior management
Coordinates destruction of rejected finished goods and assures destruction occurs in a timely manner
Expedites and prioritizes product releases by coordinating the Review, testing, and releases with site management to meet customer service requirements
Conducts routine investigation and departmental meetings to facilitate the performance of release function
Manages personnel for in-process filling and inspection/packaging monitoring
Provide QA oversight of Operation for the entire Manufacturing process, supporting Clean room technicians and production technicians as needed to identify and address product quality compliance issues as they arise
Provide training and assistance to all Clean room and operation personnel for NCR, CAPA and Change Control
Provides QA review and approval of manufacturing investigations assuring timely review, follow-up, tracking and trending of MIRs. Perform Root Cause analysis and assure corrective action (CAPA) implementation associated with manufacturing investigations. Provide guidance to the investigation scientists on reporting and metrics required for different levels within organization
Performs QA review and approval of LIR’s (Laboratory Investigation Reports)
Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR’s, Commissioning Documents, FAT’s), engineering documents
Establish a qualification and Requalification program for Clean Room Certification and Recertification, for ISO 5 and 7 environments
Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff
Assists the QA management in developing on department budget
Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions
Manages attendance records for all direct reports
Qualification
Required
Minimum: Bachelor's degree in Pharmacy, Biology, Chemistry or a related field
Minimum: Five years of professional experience in Compounding Facilities/Pharmaceutical Industry
Must have history of strong documentation skills and attention to detail
Familiarity with cGMPs and CFR for US and EU
Excellent organizational skills and ability to multi-task and perform work in a timely manner
Demonstrates ability to lead a department, projects and meetings effectively
Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management
General computer skills and ability to prepare presentations and address large groups
Demonstrated attention to details and accuracy
The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must
Mentoring abilities as well as effective communication, (written and oral) are required
Preferred
Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial
Benefits
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
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.
Company
Hikma Pharmaceuticals
Hikma focuses on a wide range of generic, branded generic and in licensed pharmaceutical products
5001-10000 employees
H1B Sponsorship
Hikma Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (23)
2023 (22)
2022 (24)
2021 (28)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
International Finance Corporation
2025-07-15Post Ipo Debt· $250M
2005-11-04IPO
Leadership Team
Said Darwazah
Chief Executive Officer
Khalid Nabilsi
Chief Financial Officer
Recent News
2026-01-09
London Evening Standard
2025-12-16
2025-12-15
Company data provided by crunchbase