To provide overall operational leadership for the IV fluids/Infusions (LVP) & Small Volume Parenteral (SVP) Products manufacturing plant at Kinshasa, DR Congo — accountable for safe, quality & regulatory compliant, and efficient day-to-day plant operations across Production, Quality Control, Engineering, Warehouse, HR/Admin and Security — while working in close partnership with all key functions of organisation. The role is also accountable for a smooth transition from project handover into full-scale commercial production, and for building the plant into a model site that can be replicated for the company's planned expansion across geographies in the future.

- Key Responsibilities

Site Operational Leadership

- Own overall accountability for the plant's day-to-day operational performance — production output, quality control execution, engineering/utilities reliability, warehouse/inventory management, and site administration/security.

- Translate corporate business objectives (set with the Managing Director/Head of Organisation) into an executable site operating plan (production volumes, cost targets, capacity utilization, opex/capex needs).

- Lead the plant through the transition from project completion/commissioning (handover from the Project Head/EPC) into stable, full-scale commercial operations.

- Build the plant as a reference/model site — documenting operational standards, systems and best practices to support the company's planned expansion to other locations across geographies.

- Represent site operations to the Managing Director/Head of Organisation, and support external interactions with regulators, government bodies and community stakeholders as required.

Cross-Functional Partnership with QA, Finance & Sales

- Work in close, structured partnership with the Quality Assurance Head — who is organizationally independent and reports directly to the MD/Head of organisation— ensuring Production and Quality Control fully support QA's compliance requirements without attempting to influence or override QA's release/rejection decisions.

- Coordinate with the Finance Head on plant operating/capex budgets, cost control initiatives, and supply chain/procurement matters affecting site operations, given Finance's corporate-wide cost-control and supply chain mandate.

- Coordinate with the Sales & Marketing Head on production planning inputs (demand forecast, order priorities, new product/tender requirements) to ensure the plant can meet commercial commitments.

- Escalate any cross-functional conflicts (e.g., production pressure vs. quality holds) to the Managing Director promptly and transparently.

Production & Quality Control Oversight

- Drive achievement of production targets (volume, yield,) through the Production Head,



ensuring manufacturing operations are executed as per approved batch records and SOPs.

- Ensure the Quality Control Head's operations (raw material, in-process and finished product testing) are adequately resourced, timely, and fully aligned with QA-approved specifications and test methods.

- Review site-level production and QC performance, deviations and corrective actions in periodic management review meetings, coordinating with QA on compliance-related matters.

- Ensure overall plant readiness for regulatory inspections, WHO Prequalification assessments, and customer/donor/NGO/Institution audits, coordinating Production, Engineering, Warehouse and QC inputs (with QA leading the compliance/audit process itself).

Engineering, Warehouse & Utilities Management

- Ensure critical utilities (WFI, pure steam, HVAC, power backup) and manufacturing equipment are maintained in a validated, reliable state through the Plant Engineer.

- Approve and prioritize site-level capex requests (equipment upgrades, capacity expansion, infrastructure improvements) for submission to the Managing Director/Finance Head.

- Ensure that Warehouse Manager maintains efficient, compliant storage and handling of raw materials, packaging materials and finished goods, with accurate inventory control.

- Ensure business continuity planning for utility/power reliability challenges typical of the operating environment, including backup power, water security and critical spares strategy.

People, Safety, Security & Organization Building

- Build, lead and develop the site operations leadership team (Production Head, Quality Control Head, Plant Engineer, Warehouse Manager, HR/Admin, Security Head); ensure succession planning for key roles.

- Direct the Plant HR & Admin function on workforce planning, local talent development and compliance with DRC labour regulations, in line with the company's local employment/localization objectives.

- Champion a strong safety culture (EHS) across the plant, ensuring statutory compliance (fire, electrical, pressure vessel, environmental/effluent) and zero significant safety incidents.

- Direct the Security Head/Agency to ensure robust site security, access control and asset protection appropriate to the operating environment.

- Ensure a positive, disciplined and performance-driven organizational culture across all site functions under direct report.





Statutory & External Stakeholder Management

- Ensure all site-level statutory licenses, permits and regulatory registrations required to operate the plant are obtained and renewed on time (in coordination with QA/Regulatory Affairs for product/manufacturing licenses and Finance for tax/statutory filings).

- Support the Managing Director and Finance Head in maintaining relationships with DRC national/local government bodies and industry associations as they relate to site operations.

- Manage site related engagements as may be required time to time.

Education & Certification

- Postgraduate / Graduate in Pharmacy, Engineering -Chemical/Mechanical, or equivalent technical degree; MBA or equivalent management qualification strongly preferred.

- Exposure to WHO GMP/cGMP and pharmaceutical regulatory frameworks through formal training or extensive career experience.

Experience

- 15–20+ years of pharmaceutical manufacturing experience, including at least 5 years as Plant Head/General Manager/Site Operations Head of a sterile/parenteral manufacturing facility.

- Proven experience running an IV fluids / Large Volume Parenteral (LVP) or injectables plant at full commercial scale.

- Experience leading a plant through commissioning/start-up into stable commercial operations is strongly preferred.

- Prior experience operating in Africa or other emerging-market/developing-infrastructure environments is highly valued.

Technical & Functional Competencies

- Solid overall understanding of WHO GMP/cGMP requirements across Production, Quality Control and Engineering functions for sterile manufacturing.

- Sound understanding of manufacturing cost drivers, production planning, and operational budgeting.

- Working knowledge of warehouse/inventory management practices for pharmaceutical raw materials and finished goods.

- Understanding of ICH Guidelines from cGMP Perspective

Behavioural Competencies

- Strong, decisive operational leadership with the ability to balance production pressure against non-negotiable quality and safety standards.

- Excellent cross-functional collaboration skills.

- Ability to build and lead a multi-functional site operations team, including in a developing operational environment.

- High resilience, hands-on presence, and sound judgment in managing infrastructure, logistics, safety and workforce challenges typical of the region.

- Strategic mindset with an eye toward building repeatable, scalable systems to support the company’s growth plans

Other Requirements

- Willingness to relocate to and be based full-time in Kinshasa, DR Congo.

- Fluency in French strongly preferred (DRC's official language); working proficiency in English required for corporate reporting.

📌 Plant Head / General Manager-Plant (Mumbai)
🏢 The Migration
📍 Mumbai