Job Scope:
The Pharmaceutical Project Manager will be responsible for overseeing the full lifecycle of establishing a new oral solid dosage (OSD) pharmaceutical manufacturing facility in the Kingdom of Saudi Arabia (KSA), from concept through design, construction, validation, and handover to operations. This role requires leadership across multi-disciplinary teams, coordination with third-party consultants and regulatory bodies, and strict adherence to international GMP standards. The ideal candidate will bring deep experience in managing complex greenfield projects in the pharmaceutical industry, particularly within KSA..
Key Responsibilities:
- Lead the end-to-end development of new manufacturing facilities: conceptual and detailed design, construction, commissioning, and operational handover.
- Manage cross-functional project teams including engineering, QA/QC, validation, production, regulatory affairs, and EHS.
- Develop and track detailed project plans, budgets, and timelines to ensure on-time and on-budget execution.
- Oversee selection and installation of key OSD equipment such as granulators, blenders, tablet presses, coaters, and packaging lines.
- Coordinate with external vendors, contractors, design firms, and regulatory consultants to meet technical and compliance requirements.
- In coordination with the main consultant (3rd party), ensure all facility design and construction work complies with FDA, EMA, ICH, and cGMP guidelines.
- Lead risk assessments and change control processes throughout the project lifecycle.
- Support facility qualification activities (DQ/IQ/OQ/PQ) in collaboration with quality and validation teams.
- Provide regular updates and progress reports to senior management and stakeholders.
Requirements:
- Bachelor's degree in Engineering (Mechanical, Electrical, Electromechanical) or a related field; PMP certification is an advantage.
- Minimum of 15 years of experience in pharmaceutical manufacturing, including at least 5 years in project management.
- Minimum of 5 years of relevant experience in the Kingdom of Saudi Arabia.
- Proven experience in establishing a new pharmaceutical factory in KSA (greenfield project).
- Strong understanding of OSD processes including blending, granulation, compression, coating, and packaging.
- Demonstrated experience in delivering GMP-compliant manufacturing facilities.
- Strong leadership, negotiation, and communication skills.
- Proficiency in project management software (e.g., MS Project, Primavera).
- PMP certification or equivalent is desirable.