Chief Quality Officer

Job Description

Nano Daru Pharmaceutical Company is seeking an experienced and strategic Chief Quality Officer (CQO) to lead the organization’s overall Quality function and provide strategic direction across all quality-related activities, as part of the Company’s continued growth and development within the pharmaceutical industry.
The CQO will provide strategic leadership and executive oversight of the organization’s Quality Management System (QMS), ensuring the sustained and effective compliance of procurement, manufacturing, quality control, warehousing, and distribution processes with applicable pharmaceutical laws and regulations, Good Manufacturing Practices (GMP), requirements of the Iran Food and Drug Administration (IFDA), relevant national and international standards, QMS requirements, and approved procedures.
Key Responsibilities
• Develop, implement, and monitor the organization’s overall quality strategy, policies, and objectives in alignment with business goals and pharmaceutical industry requirements.
• Provide strategic leadership and oversight of the Quality Assurance (QA) and Quality Control (QC) functions, ensuring the integration, consistency, and effectiveness of their activities.
• Oversee procurement, manufacturing, quality control, warehousing, and distribution processes to ensure compliance with GMP requirements, IFDA requirements, applicable national and international standards, and approved procedures.
• Ensure the effective implementation, maintenance, and continual improvement of the Quality Management System (QMS)
• Lead and oversee processes related to Quality Risk Management, Deviations, CAPA, Change Control, OOS/OOT, Product Complaints, and Product Recalls.
• Oversee internal audit programs and supplier audits, and ensure organizational readiness for inspections conducted by relevant regulatory and competent authorities.
• Lead and oversee activities related to ensuring the safety, efficacy, and quality of products in accordance with applicable legal and regulatory requirements.
• Oversee the processes for obtaining, renewing, amending, and maintaining pharmaceutical product manufacturing licenses, and manage effective interactions with the IFDA and other relevant regulatory authorities.
• Ensure the adequacy and effectiveness of validation and qualification processes
• Monitor key Quality Performance Indicators (KPIs) and provide analytical reports, insights, and improvement recommendations to senior management.
• Lead and oversee organization-wide CAPA activities, ensuring the timely identification, investigation, and effective resolution of the root causes of non-conformities
• Foster a strong quality culture, increase employees’ awareness of quality requirements, and embed a quality-focused mindset across all levels of the organization.
• Contribute to strategic organizational decision-making on matters related to quality, risk management, regulatory compliance, and product supply.
Job Requirements
Education
• Master’s degree in Pharmacy, Chemistry, Chemical Engineering, Biological Sciences, Microbiology, Biochemistry, or other related fields.
Professional Experience
• At least 10 years of relevant work experience in the pharmaceutical industry.
• At least 5 years of senior management experience in Quality, preferably in positions such as Quality Assurance Manager, Quality Control Manager, Technical Responsible Person, or equivalent senior-level roles.
• Proven experience in successfully managing GMP inspections and internal and external audits.
• Experience in obtaining, renewing, or amending pharmaceutical product manufacturing licenses
Knowledge & Expertise
• Strong knowledge and practical understanding of GMP and pharmaceutical industry requirements.
• Strong knowledge of IFDA requirements, guidelines, and applicable laws and regulations governing the pharmaceutical industry.
• Strong knowledge of Quality Management System (QMS) principles and practices.
• In-depth understanding of Quality Risk Management (QRM) principles.
• Strong knowledge of Deviation, CAPA, Change Control, OOS/OOT, Complaint, and Recall processes.
• Knowledge of Validation and Qualification principles and requirements applicable to processes, equipment, and systems.
• Strong understanding of quality requirements across the pharmaceutical supply chain, manufacturing, warehousing, and distribution processes.
• Familiarity with Data Integrity requirements and pharmaceutical documentation principles.
• Familiarity with relevant ISO standards applicable to the pharmaceutical industry, as well as ICH, PIC/S, and WHO GMP requirements, is considered an advantage.
Management & Behavioral Competencies
• Ability to provide strategic leadership and ensure the effective integration of specialized Quality functions.
• Strong strategic decision-making, risk analysis, and crisis management skills.
• Excellent leadership skills with the ability to lead specialized and multidisciplinary teams.
• Strong ability to effectively engage and collaborate with senior management, IFDA, auditors, and other key stakeholders.
• Strong problem-solving, root cause analysis, and corrective action leadership skills.
• Ability to develop strategies, establish priorities, and monitor organizational performance.
• A results-oriented, systematic, quality-driven, and compliance-focused approach.