# Biologics Quality Control Section Head

**Company:** [Eva Pharma](https://jobs.workable.com/companies/cVu9CoRuY1pLdxtN9NyNNA.md)
**Location:** 6th of October City, Egypt
**Workplace:** on site
**Employment type:** Full-time
**Department:** Operations Business Division

[Apply for this job](https://jobs.workable.com/view/8b1be905-7725-4162-a4f9-ebc76a06ebc9)

## Description

Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.

Job Summary

We are seeking an experienced **Biologics QC Section Head** to lead laboratory operations, ensuring the quality, safety, and compliance of biological and biosimilar products through robust analytical testing and biological activity assessment.

**Key Responsibilities:**

-   Lead QC testing and characterization of biological and biosimilar products in compliance with GMP requirements and approved specifications.
-   Oversee analytical testing using LC-MS/QTOF, HPLC, ELISA, IEF, SDS-PAGE, and microplate readers.
-   Lead bioassay testing for biological activity and potency, including assay execution, data interpretation, troubleshooting, and validation, ensuring reliable and scientifically sound results.
-   Manage analytical method transfer, verification, validation, and troubleshooting for new and existing products.
-   Review analytical data and lead investigations into OOS/OOT results, deviations, and laboratory incidents, ensuring effective root-cause analysis and CAPA implementation.
-   Oversee stability testing and evaluation of biological product stability data.
-   Ensure compliance with GMP, data integrity requirements, and applicable regulatory standards.
-   Lead and develop the QC team, ensuring timely testing, laboratory efficiency, and continuous improvement.
-   Support internal and external audits and regulatory inspections.

## Requirements

-   Bachelor’s degree in Science, Biochemistry, Biotechnology, or a related field.
-   6+ years of experience in quality control or quality assurance within the pharmaceutical or related industry.
-   Hands-on experience in bioassay testing, biological activity and potency assessment, and assay validation is essential.
-   Practical experience with LC-MS/QTOF, HPLC, ELISA, IEF, SDS-PAGE, and microplate reader-based techniques.
-   Strong knowledge of GMP, data integrity, laboratory investigations, and pharmaceutical quality systems.
-   Previous experience in team leadership or supervision is preferred.