Manufacturing Operations Manager

Role Summary

the Manufacturing Operations Manager is responsible for the full operational management of the manufacturing facility, ensuring production targets, quality standards, regulatory compliance, and safety requirements are met. The role oversees daily plant operations, leads the production and technical teams, and ensures the facility operates in line with medical-grade manufacturing standards and applicable health authority regulations.

Key Responsibilities

Production & Operations

• Plan, organize, and oversee daily production activities to meet output targets, quality benchmarks, and delivery timelines.

• Manage production schedules, capacity planning, and workflow across all shifts.

• Monitor key production KPIs (output, yield, downtime, scrap rate, OEE) and drive continuous improvement.

• Ensure efficient use of raw materials, equipment, and labor to control costs.

Quality & Compliance

• Ensure all manufacturing activities comply with ISO 13485 and applicable medical device regulations.

• Oversee quality control processes, in-line inspections, and final product release.

• Liaise with regulatory bodies and ensure the facility remains audit-ready at all times.

• Maintain proper documentation, batch records, and traceability systems.

Health, Safety & Environment

• Enforce strict adherence to occupational health, safety, and hygiene standards.

• Ensure cleanroom and controlled environment protocols are maintained where applicable.

• Lead incident investigations and implement corrective and preventive actions (CAPA).

People Management

•  Lead, develop, and supervise production supervisors, technicians, and operators.

• Build a strong shift management structure and ensure adequate staffing levels.

• Drive a culture of accountability, discipline, and continuous learning across the plant.

Maintenance & Equipment

• Oversee preventive and corrective maintenance of all production machinery and utilities.

• Coordinate with engineering and technical teams to minimize downtime and extend equipment life.

Reporting & Stakeholder Management

• Submit regular production, quality, and operational reports to senior management.

• Coordinate with supply chain, procurement, quality, and commercial functions to align operations with business objectives.

• Manage relationships with equipment suppliers, raw material vendors, and third-party service providers.

Requirements

Education & Certification

• Bachelor's degree in pharmacy, Biomedical Engineering, Chemical Engineering, Industrial Engineering, or related field.

• A valid medical certificate / professional license issued by the relevant health authority is

Experience

• Minimum 5–7 years of experience in manufacturing operations, with at least 3 years in a senior plant or factory management role.

• Prior experience in medical device, pharmaceutical, or other regulated manufacturing environments is required.

• Proven track record of managing production lines in a cleanroom or controlled-environment setting.

Skills & Competencies

• Strong knowledge of quality management systems and regulatory compliance.

• Solid understanding of production planning, lean manufacturing, and process optimization.

• Excellent leadership, decision-making, and problem-solving skills.

• Strong financial acumen and ability to manage operational budgets.

• Effective communication skills in English; Kurdish and/or Arabic is a plus.

• Proficient in ERP systems and MS Office.