QA Compliance Manager

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

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 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 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.

Qualifications and Experience:

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.

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!