Job Opportunity – Factory Manager Healthcare Sector

Our Client is looking for a Factory Manager to lead the setup of a medical device manufacturing facility (Rapid Diagnostic Tests).

Key Responsibilities:

Regulatory Compliance and Readiness

• Lead the development and implementation of the QMS aligned with ISO 13485 and GMP requirements.
• Define regulatory strategy for upcoming RDT product registrations, submissions, and inspections; prepare documentation plans and timelines.
• Establish regulatory milestones, gap analyses, and readiness checklists for audits, inspections, and supplier qualifications.
• Liaise with regulatory bodies, notified bodies, and consultants to secure guidance and alignment.

SOP Development and Documentation

• Create, validate, and maintain SOPs covering quality, regulatory, manufacturing, supplier management, and site operations.
• Develop work instructions, process maps, and record-keeping templates to support compliant product development and eventual manufacturing.
• Implement robust document control practices, versioning, and audit trails to ensure audit readiness.

Quality Management System Implementation

• Design and roll out core QMS processes (document control, CAPA, changes, deviations, training, supplier quality, internal audits).
• Establish quality metrics and dashboards; implement CAPA systems with timely closure and effectiveness verification.
• Define product release criteria, qualification/validation plans, and risk-based decision-making processes.

Stakeholder Management and Governance

• Establish governance structures (steering committees, cross-functional workstreams) to align regulatory, quality, operations and finance.
• Manage expectations with internal leadership, external partners, suppliers, and regulatory consultants.
• Prepare and deliver regular status updates, risk disclosures, and milestone reporting to senior management.

Resource and Capacity Planning

• Assess and organize initial resource needs (personnel, equipment, facilities, and budget) for readiness activities.
• Develop a recruitment, onboarding, and training plan focused on quality systems, regulatory requirements, and GMP hygiene.
• Define contingency plans and scalable staffing models for the transition to production.

Risk Management and Compliance Assurance

• Implement risk assessment methods to identify regulatory, quality, and operational risks; establish mitigations and monitoring.
• Lead change control processes for process, equipment, and documentation that could impact regulatory compliance.
• Develop risk-based supplier qualification and auditing plans to ensure material quality and integrity.

Process Development and Transfer Readiness

• Carry out research to translate product concepts into manufacturing-ready processes; define process validation strategy aligned with regulatory expectations.
• Establish pre-production/ pilot plans, sampling strategies, and data collection protocols to support future scale-up.
• Create line-of-sight plans for product transfer from development to manufacturing, including documentation and traceability requirements.

Training and Culture Building

• Develop a comprehensive training curriculum on QMS, regulatory requirements, quality practices, and basic manufacturing controls.
• Foster a culture of quality, compliance, transparency, and proactive risk reporting.

Documentation and Audit Readiness

• Compile and maintain essential documentation for internal readiness reviews and external audits.
• Prepare for and coordinate anticipated regulatory inspections and third-party audits.

Health, Safety, and Environmental Foundations

• Establish initial HSE policies and training aligned with local regulations and global best practices to ensure a safe setting for readiness activities.

Program Management and Milestone Tracking

• Define and manage project plans with clear milestones, owners, and success criteria for regulatory and quality milestones.
• Identify interdependencies across functions and manage cross-functional risks and timelines.

Skills Requirement

• Knowledge of GMP and ISO 13485
• Experience building or implementing a QMS
• Familiar with regulatory submissions and inspections (ZMRA knowledge a plus)
• Proficient at writing and updating SOPs and work instructions
• Strong document control and audit-trail practices
• Ability to manage cross‑functional tasks with clear milestones
• Strong communication with regulators, suppliers, and teams
• Basic risk management (FMEA) and CAPA understanding
• Change control and supplier qualification awareness
• Experience in process development/validation (IQ/OQ/PQ)
• Planning for readiness activities and early-stage production
• Ability to plan resources, budget, and timelines for setup
• Comfortable using ERP/QMS software and basic data reporting
• Leadership readiness for a small, growing team; collaborative mindset

Qualifications

• Education: Bachelor’s degree in Biomedicine, Pharmacy, Medical Laboratory Science, Biomedical Engineering, or a closely related field. Master’s degree or MBA is a plus.
• Experience: Minimum 5 years of manufacturing leadership or regulatory/compliance experience in medical devices, diagnostics, or related sectors; experience with RDTs preferred. Prior exposure to startup or early-stage facility setup is advantageous.
• Regulatory Knowledge: Understanding of GMP, ISO 13485; familiarity with local regulatory expectations (ZMRA) and potential regional requirements; exposure to CE/FDA pathways is a plus if planning exports.
• Quality & Process: Experience with QMS implementation, CAPA, change control, risk management, and process validation (IQ/OQ/PQ).
• Operations: Basic knowledge of production planning, capacity management, equipment qualification, and EHS compliance; readiness-focused mindset.
• Data/Technology: Comfort with ERP systems (e.g., SAP, Oracle), MES/LIMS, document control software; ability to build basic data dashboards.
• Leadership: Demonstrated ability to lead cross-functional teams, manage stakeholders, and influence without formal authority.
• Communication: Strong written and verbal communication; ability to engage with regulators, suppliers, and internal teams.
• Problem-Solving: Structured, data-driven approach to risk identification and mitigation.

• Lead the development and implementation of the QMS aligned with ISO 13485 and GMP requirements.
• Define regulatory strategy for upcoming RDT product registrations, submissions, and inspections; prepare documentation plans and timelines.
• Establish regulatory milestones, gap analyses, and readiness checklists for audits, inspections, and supplier qualifications.
• Liaise with regulatory bodies, notified bodies, and consultants to secure guidance and alignment.
• Create, validate, and maintain SOPs covering quality, regulatory, manufacturing, supplier management, and site operations.
• Develop work instructions, process maps, and record-keeping templates to support compliant product development and eventual manufacturing.
• Implement robust document control practices, versioning, and audit trails to ensure audit readiness.
• Design and roll out core QMS processes (document control, CAPA, changes, deviations, training, supplier quality, internal audits).
• Establish quality metrics and dashboards; implement CAPA systems with timely closure and effectiveness verification.
• Define product release criteria, qualification/validation plans, and risk-based decision-making processes.
• Establish governance structures (steering committees, cross-functional workstreams) to align regulatory, quality, operations and finance.
• Manage expectations with internal leadership, external partners, suppliers, and regulatory consultants.
• Prepare and deliver regular status updates, risk disclosures, and milestone reporting to senior management.
• Assess and organize initial resource needs (personnel, equipment, facilities, and budget) for readiness activities.
• Develop a recruitment, onboarding, and training plan focused on quality systems, regulatory requirements, and GMP hygiene.
• Define contingency plans and scalable staffing models for the transition to production.
• Implement risk assessment methods to identify regulatory, quality, and operational risks; establish mitigations and monitoring.
• Lead change control processes for process, equipment, and documentation that could impact regulatory compliance.
• Develop risk-based supplier qualification and auditing plans to ensure material quality and integrity.
• Carry out research to translate product concepts into manufacturing-ready processes; define process validation strategy aligned with regulatory expectations.
• Establish pre-production/ pilot plans, sampling strategies, and data collection protocols to support future scale-up.
• Create line-of-sight plans for product transfer from development to manufacturing, including documentation and traceability requirements.
• Develop a comprehensive training curriculum on QMS, regulatory requirements, quality practices, and basic manufacturing controls.
• Foster a culture of quality, compliance, transparency, and proactive risk reporting.
• Compile and maintain essential documentation for internal readiness reviews and external audits.
• Prepare for and coordinate anticipated regulatory inspections and third-party audits.
• Establish initial HSE policies and training aligned with local regulations and global best practices to ensure a safe setting for readiness activities.
• Define and manage project plans with clear milestones, owners, and success criteria for regulatory and quality milestones.
• Identify interdependencies across functions and manage cross-functional risks and timelines.

• Knowledge of GMP and ISO 13485
• Experience building or implementing a QMS
• Familiar with regulatory submissions and inspections (ZMRA knowledge a plus)
• Proficient at writing and updating SOPs and work instructions
• Strong document control and audit-trail practices
• Ability to manage cross‑functional tasks with clear milestones
• Strong communication with regulators, suppliers, and teams
• Basic risk management (FMEA) and CAPA understanding
• Change control and supplier qualification awareness
• Experience in process development/validation (IQ/OQ/PQ)
• Planning for readiness activities and early-stage production
• Ability to plan resources, budget, and timelines for setup
• Comfortable using ERP/QMS software and basic data reporting
• Leadership readiness for a small, growing team; collaborative mindset

• Bachelor’s degree in Biomedicine, Pharmacy, Medical Laboratory Science, Biomedical Engineering, or a closely related field. Master’s degree or MBA is a plus.
• Minimum 5 years of manufacturing leadership or regulatory/compliance experience in medical devices, diagnostics, or related sectors; experience with RDTs preferred. Prior exposure to startup or early-stage facility setup is advantageous.
• Understanding of GMP, ISO 13485; familiarity with local regulatory expectations (ZMRA) and potential regional requirements; exposure to CE/FDA pathways is a plus if planning exports.
• Experience with QMS implementation, CAPA, change control, risk management, and process validation (IQ/OQ/PQ).
• Basic knowledge of production planning, capacity management, equipment qualification, and EHS compliance; readiness-focused mindset.
• Comfort with ERP systems (e.g., SAP, Oracle), MES/LIMS, document control software; ability to build basic data dashboards.
• Demonstrated ability to lead cross-functional teams, manage stakeholders, and influence without formal authority.
• Strong written and verbal communication; ability to engage with regulators, suppliers, and internal teams.
• Structured, data-driven approach to risk identification and mitigation.