Job Opportunity – Factory Manager Healthcare SectorJob board platform

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.