DEMO S.A. is a Greek industrial and commercial organization, specializing in the production, sales and distribution of injectable drugs. We are bringing the future into the present, with a 356 million Euro investment plan, which is already underway. DEMO is stepping up to become a European and global leader in the manufacture of injectables by 2027; by constructing four new production units in Tripoli, by building a small-scale manufacturing unit for the development and production of monoclonal antibodies, by investing heavily in R&D and by expanding its existing manufacturing plants in Kryoneri.
We are looking for a talented Group Quality Assurance Director; the main purpose of this role is to establish and oversee DEMO’s overall QA strategy, ensuring that our products meet not only all regulatory requirements and industry standards, but our own strict internal standards.
This role is crucial in the development of the QA Operational Strategy for the new manufacturing hubs and expansions, in supervising the implementation and maintenance of the quality systems and in leading the QA teams (Systems, Operations, Validation and Qualification, Biotechnology) to foster a common culture of continuous improvement and compliance.
Key Responsibilities:
- Lead and manage the Quality Assurance (QA) departments and oversee the overall QA strategy and processes, while inspiring and aligning the teams towards achieving the company's strategic objectives and ensuring sustained business success.
- Build robust Quality Assurance Systems across the company that meet all regulatory requirements, industry standards and high internal standards and provide strategic guidance for the new entities.
- Influence the interpretation and implementation of policies, fostering collaboration across functions to meet QA standards.
- Provide leadership and expertise in the interpretation, development and implementation of current and new manufacturing divisions’ policies.
- Provide the management team with data concerning the results of internal audits and compliance and remediation performance indicators.
- Ensure that all manufacturing processes and products meet the highest quality standards and comply with regulatory requirements.
- Establish and promote a unified approach of QA culture across the organization as a whole.
- Lead cross-functional teams as necessary for the development, review and implementation of SOPs and GMPs
- Bachelor’s degree in Chemical Engineering, Chemistry, Pharmacy, Biology or a related field; MSc Degree in Quality Management or a relevant field is an asset.
- Minimum of 10 years of experience effectively leading Quality Assurance teams in the pharmaceutical industry.
- Extensive knowledge of GMP, FDA, EMA, and other relevant regulatory guidance and requirements.
- Experience in developing and implementing quality systems and driving strong GMP practices within a manufacturing organization and sites.
- Experience in handling regulatory interfaces such as inspections and external audits.
- Strong people management skills
- Strong problem-solving skills, including in-depth knowledge of Root Cause Analysis methodology.
- Ability to create a performance culture, drive results, prioritize tasks, and execute plans effectively.
- Fluent in Greek and English.
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
