QA Compliance Manager
Cairo, Egypt
Arcera is a global life sciences company, headquartered in Abu Dhabi. Arcera develops, manufactures, and commercializes a broad range of high-quality proven and innovative medicines in key international markets. Its portfolio exceeds 2,000 medicines covering wide therapeutic areas which reach patients in 120 countries in five continents, backed by manufacturing and packing sites across the world. Arcera was established by the sovereign wealth fund, ADQ to realize Abu Dhabi’s ambition as a global leader in innovative and sustainable healthcare.
The Position
The Role
The role supports the Arcera Corporate Quality (CQ) with a particular focus on the maintenance of the internal and external Audit processes including annual audit program, inspection management as well as recall, escalation management and global process ownership for dossier compliance check process. Candidate should be comfortable working in a fast-paced, dynamic environment and embrace change.
Your Opportunities
- 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 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.
Who You Are
- 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 Are Arcera
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.
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 build 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.
How To Apply
Note that only direct applications via our HR system will be considered.