VP of Quality Assurance

Job Description

HR Bamboos connects exceptional professionals with reputable organizations across Iran and international markets.

We are seeking an experienced and capable VP of Quality Assurance to join our client, a holding company active in the medical device sector. This individual will play a key role in ensuring the quality and safety of products, particularly diagnostic and laboratory kits, by overseeing the compliance of production and quality control processes with national and international standards.

Key Responsibilities
• Design and implement Quality Management Systems (QMS) across the holding's subsidiary companies.
• Oversee the execution of quality standards and guidelines throughout manufacturing processes.
• Plan and manage internal and external audits.
• Supervise the identification of quality issues and implement Corrective and Preventive Actions (CAPA).
• Manage risk assessment processes and the validation of equipment and manufacturing processes.
• Ensure product compliance with regulatory standards and requirements.
• Collaborate closely with Production, R&D, and QC departments to elevate quality performance.
• Foster a culture of quality and enhance employee awareness regarding quality requirements.
• Provide periodic QMS performance reports to the holding's senior management.

What You Bring
• Minimum of 10 years of experience in QA/QC, including at least 5 years in a managerial role within the pharmaceutical, medical device, or IVD industries.
• Master's or Ph.D. degree in Pharmacy, Biomedical Engineering, Biotechnology, Chemistry, Microbiology, or related fields.
• Mastery of ISO 13485, ISO 9001, and ISO 14971 standards, as well as GMP and GLP requirements.
• Comprehensive knowledge of IMED (Iran's Medical Equipment Directorate) and local Food and Drug Administration regulations.
• Proven track record of establishing and improving Quality Management Systems in manufacturing companies.
• Strong leadership skills with the ability to manage specialized teams and interact effectively with senior executives.
• High attention to detail, strategic thinking, and the ability to make critical decisions under pressure.

Nice To Have
• Experience working in companies manufacturing diagnostic kits and IVD products.
• Experience managing quality systems in corporate holdings and multi-subsidiary organizations.
• Familiarity with CE Marking and FDA requirements.
• Experience in the validation of equipment, production lines, and laboratory software.
• Proven track record of direct interaction with domestic and international regulatory bodies.

What We Offer
• Supplementary insurance
• Bonus
• Loan

We look forward to reviewing your application and exploring this opportunity with you.
Apply now
We maintain the highest level of confidentiality throughout the recruitment process.