GMP & Quality Operations Executive

Onko İlaç Tic. A.Ş.

We are looking for a GMP & Quality Operations Executiveto join our state-of-the-art pharmaceutical manufacturing facility located in Gebze Organized Industrial Zone.

This position is responsible for ensuring the effective management of GMP compliance activities and quality operations processes, maintaining the sustainability of the Quality Management System, and promoting a strong quality culture throughout the organization.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field.
• Minimum 7 years of experience in Quality Assurance, GMP Compliance, or Quality Operations within the pharmaceutical industry.
• Strong knowledge and experience in GMP requirements, quality systems, and international pharmaceutical regulations.
• Advanced level of English proficiency with excellent verbal and written communication skills; capable of confidently leading meetings, audits, inspections, and technical discussions with international customers, business partners, auditors, and health authorities.
• Proficient in Microsoft Office applications; experience with SAP and electronic Quality Management Systems is preferred.
• Experience in supplier qualification, quality agreements, audit management, and quality risk management processes.
• Strong leadership, team management, and cross-functional coordination skills.
• Excellent analytical thinking, problem-solving, and organizational abilities.
• Result-oriented, proactive, and possessing strong interpersonal and communication skills.
• For male candidates, completion of military service.
• Residing in or willing to relocate to Istanbul (Asian Side) or Kocaeli/Gebze region.

Key Responsibilities

• Ensure the effective execution and continuous improvement of GMP compliance and quality operations processes.
• Manage supplier qualification, supplier performance evaluation, and approved supplier programs.
• Coordinate the preparation and management of supplier, customer, and contract manufacturing quality agreements.
• Lead internal audits, supplier audits, customer audits, and regulatory authority inspections.
• Lead the development, implementation, maintenance, and periodic review of the Contamination Control Strategy (CCS).

·        Coordinate artwork creation, review, approval, and lifecycle management processes, ensuring compliance with regulatory and company requirements.

• Lead routine GMP shop floor inspections and quality oversight activities across manufacturing, warehouse, laboratory, and supporting areas.
• Ensure that deviation management, change control, CAPA, document management, and annual product review processes are carried out in compliance with GMP requirements.
• Lead quality risk assessment activities and ensure effective implementation of related actions.
• Manage communications related to quality processes with local and international customers, business partners, and regulatory authorities.
• Lead the evaluation, investigation, and resolution of customer complaints and quality-related events.
• Provide Quality Assurance support for regulatory affairs, contract manufacturing, and alternative source qualification activities.
• Maintain the Site Master File and ensure the continuous update of quality documentation.
• Lead initiatives aimed at strengthening GMP awareness and quality culture throughout the organization.
• Monitor departmental objectives, performance indicators, and quality metrics to ensure achievement of quality goals.

What We Offer

• The opportunity to work in a modern, technology-driven pharmaceutical manufacturing facility.
• Exposure to international customers, business partners, and regulatory authorities.
• The opportunity to play a strategic role in the development and continuous improvement of quality systems.
• A dynamic work environment that promotes continuous learning and career development.

We welcome applications from professionals with a strong background in quality, compliance, and operational excellence who are eager to take on a leadership role within a Quality organization.