
QA Compliance Manager
Primary stack
Nice to have's
Job description
QA Compliance Manager
About the Position
Arcera, a global life sciences company headquartered in Abu Dhabi, is seeking a QA Compliance Manager to join their team in Cairo, Egypt. This role focuses on maintaining internal and external audit processes, ensuring regulatory compliance, and supporting the strategic development of a global risk-based audit strategy.
Responsibilities
- Responsible for planning activities of Quality audits within the Arcera network, including establishing and updating the Global Annual Quality Audit plan.
- Identify areas of risk and provide independent assessments on the impact of audited activities.
- Support the strategic development of an effective global risk-based audit strategy and program.
- Monitor the global annual external/internal audit plan and inspection/customer audit plan.
- Maintain current knowledge of regulations, standards, and guidance documents.
- Act as the global process owner for Regulatory compliance checks process including ownership of the respective procedures.
- Lead Global Escalation Management within ARCERA.
- Support the Inspection Readiness program at ARCERA Sites/offices.
- Support maintenance and improvements of computerized Quality Audit and Supplier Management Tools.
- Establish and maintain global SOPs under the responsibility of GxP audits and Compliance.
- Support execution of corporate Internal Audits within the Arcera network if and when needed.
- Provides site/local/regional QA teams with guidance on GxP topics.
- Provide GxP training as applicable.
Requirements
- Bachelor’s or master’s degree in pharmacy, chemistry, biology, engineering, or another related science.
- At least 10 years’ QA experience in the Pharmaceutical Industry preferably including GxP auditing experience.
- Excellent oral and written communication skills in Business English.
- Knowledge and understanding of the EU, PICs, WHO, and other relevant GxP guidelines and regulations.
- Knowledge and understanding of ISO 9001, ISO 13485, ISO 22716, ISO 22000 is a plus.
- General knowledge of technical, chemical, and pharmaceutical processes, validation procedures, and analytical methodology.
- Capable of understanding and overcoming different cultural and language obstacles to provide solutions that satisfy corporate, regional, and local objectives.
- Self-motivation, flexibility, and a high level of individual responsibility.
- Eagerness to learn and continuously improve.
We Offer
At Arcera, you can:
- Drive meaningful change in healthcare and patient outcomes.
- Accelerate your career through mentorship and continuous development.
- Collaborate freely in a culture built on ownership, transparency, and work–life balance.
- Thrive and innovate in a dynamic, fast-growing environment, as One Arcera.
Arcera is an Equal Opportunity Employer.
About the Company
At Arcera, we are united by our bold ambition to be a catalyst for change; proudly progressing the way the world heals, thrives, and evolves. We bring together the most advanced science, technology, and passionate people to innovate smarter health and wellbeing solutions, so patients can live longer, healthier lives. By working together with open minds, we create lasting impact for patients, communities, and the future of healthcare.
How To Apply
Note that only direct applications via our HR system will be considered.
© Acino. This job description was sourced from the employer's public career page. TheJob is not the employer — we index the posting and route candidates to the source. All content rights and hiring decisions belong to the employer.
As a Swiss pharmaceutical company headquartered in Zurich, we develop, manufacture and internationally market well-proven and innovative pharmaceuticals in novel drug delivery forms.
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