Part-Time
Quality Compliance Manager
Eva Pharma
1,001-5,000 employees
Produces affordable medicines for global access
No salary listed
Remote in Germany
Remote
Bachelor's
 Biology & Biotech (1) |
|---|
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- A degree in Pharmacy, Life Sciences, or a related scientific discipline.
- A minimum of 5–7 years of experience in pharmaceutical or healthcare quality management systems.
- Experience as a Responsible Person for Wholesale Distribution under the German Medicines Act (AMG §52a).
- Strong knowledge of GxP requirements, German pharmaceutical regulations, and European Union compliance standards.
- Ability to manage multiple quality activities and interact effectively with internal and external stakeholders.
- Maintain and continuously improve the local Quality Management System.
- Manage quality documentation, including standard operating procedures, forms, records, and periodic reviews.
- Coordinate employee training, qualification programs, and compliance records.
- Lead supplier, customer, and service provider qualification activities.
- Plan, conduct, and follow up on internal audits and quality assessments.
- Manage deviations, quality events, corrective and preventive actions, and process improvement initiatives.
- Oversee quality-related interfaces with manufacturers, external service providers, and batch release partners.
- Prepare for, coordinate, and support regulatory authority inspections while ensuring ongoing inspection readiness.
EVA Pharma develops and manufactures affordable medicines for global markets, focusing on 12 therapeutic areas such as anti-infectives, metabolic health, oncology, and pediatrics. It operates four manufacturing facilities with a 5,000-strong team and produces over one million healthcare products daily. The company runs two regional research centers that use AI-driven prediction and mRNA R&D to develop biological products and first-of-its-kind capabilities in the Middle East and Africa. EVA Pharma distributes its products to more than 60 countries and seeks to expand access to high-quality medicines worldwide. Its differentiation comes from its scale, regional R&D capabilities, and commitment to sustainable access, aiming to meet pressing, unmet disease needs with reliable supply.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Al Sharikat, Egypt
Founded
1997
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Simplify's Take
What believers are saying
- Egypt’s December 2024 insulin approval opens exportable manufacturing revenues and credibility with regulators.
- November 2025 EVA Pharma Oncology targets 22 million packs annually, with 11 more treatments planned.
- Access-heavy partnerships with Gilead, BeiGene, and Porton create multiple near-term revenue streams.
What critics are saying
- Gilead’s generic lenacapavir supply starts 2027, so execution delays destroy EVA Pharma’s moat.
- Oncology launches need Egypt market uptake; BRUKINSA, TEVIMBRA, and seven in-house products face entrenched competitors.
- Any FDA, EDA, or Gilead tech-transfer setback blocks EVA Pharma’s pivot into high-value biologics.
What makes Eva Pharma unique
- Egypt’s 2024 Lilly insulin approval proves EVA Pharma can localize complex biologics manufacturing.
- The 2024 Gilead lenacapavir license makes EVA Pharma Africa’s sole local generic producer.
- The 2025 BeiGene deal and 2025 Porton MOU extend EVA Pharma beyond generics into oncology and CAR-T.
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Company News
The collaboration will combine Porton Advanced's capabilities in manufacturing viral vectors and cell therapies with EVA Pharma's expanding presence in the high-tech biopharmaceutical sector.
This milestone stems from the companies' collaboration to expand access to affordable insulin to one million people living with diabetes in low- to middle-income countries annually by 2030INDIANAPOLIS and CAIRO, Dec. 17, 2024 /PRNewswire/ -- The Egyptian Drug Authority approved the insulin glargine injection manufactured by EVA Pharma through a collaboration with Eli Lilly and Company (NYSE: LLY). Launched in 2022, the collaboration aims to deliver a sustainable supply of high-quality, affordable human and analog insulin to at least one million people annually living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa. This marks the first regulatory approval of EVA Pharma's insulin drug products, following Lilly and EVA Pharma's collaboration announcement in December 2022. Under this agreement, Lilly has been supplying its active pharmaceutical ingredient (API) for insulin to EVA Pharma at a significantly reduced price and providing pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges
In December 2022, Lilly announced an agreement with EVA Pharma to enhance sustainable access to affordable insulin in 56 low- and middle-income countries, mostly in Africa.
EVA Pharma is also developing its own COVID-19 vaccine and is pursuing further clinical research on next-generation vaccines.