Pharmaceutical Site Director - (Al Shifa Project - Kuwait)

Mezzan

Role & responsibilities

1. Leadership & Site Management

• Provide overall leadership and strategic direction for the factory.
• Establish a high-performance culture emphasizing safety, quality, compliance, and productivity.
• Build and mentor a multidisciplinary team covering production, engineering, QA/QC, supply chain, EHS, and support functions.

2. Greenfield Project Management

• Lead the commissioning, validation, and qualification of new production lines (BFS, ampoule, vial, lyophilizer).
• Oversee construction, equipment installation, utilities, and infrastructure development.
• Collaborate with project management, engineering contractors, and regulatory consultants to ensure timely and compliant project delivery.

3. Production Operations

• Ensure smooth startup, scale-up, and commercial operation of all manufacturing lines.
• Drive efficiency, yield optimization, and continuous improvement initiatives (Lean, Six Sigma, OEE).
• Implement and monitor key production KPIs (output, cost, cycle time, quality, safety).

4. Quality & Compliance

• Guarantee full compliance with cGMP, regulatory guidelines, and internal quality standards.
• Oversee audit readiness and lead interactions with regulatory authorities.
• Work closely with QA/QC to ensure robust validation, documentation, and change control systems.

5. Engineering & Technical Services

• Oversee maintenance, calibration, and utilities (HVAC, purified water, clean steam, compressed gases, etc.).
• Ensure high reliability and minimal downtime of critical equipment and infrastructure.

6. Financial & Strategic Responsibilities

• Manage site budgets (CAPEX and OPEX).
• Optimize resource allocation to achieve cost-effective production.
• Participate in long-term business planning and capacity expansion strategies.

7. Stakeholder Management

• Act as the primary interface with corporate management, regulatory authorities, and key external partners.
• Ensure alignment of factory objectives with overall business goals.

Qualifications & Experience

• Education: Degree in Pharmacy, Chemical/Mechanical/Industrial Engineering, or related field. Masters or MBA preferred.
• Experience:
• Minimum 15 to 20 years in pharmaceutical manufacturing, with at least 5 to 7 years in senior leadership (Factory/Plant Director, Site Head, or equivalent).
• Proven track record in greenfield or large-scale facility start-up projects.
• Deep technical knowledge of aseptic manufacturing and sterile dosage forms (BFS, ampoules, vials, lyophilization).
• Hands-on experience with validation, qualification, and regulatory audits (FDA, EMA, WHO, PIC/S).
• Skills:
• Strong leadership, people management, and cross-functional collaboration.
• Expertise in Lean Manufacturing / Six Sigma methodologies.
• Strategic planning, financial acumen, and business orientation.
• Excellent communication and stakeholder management skills.