Location: Dahej , Gujarat
Reporting To: Head of Operations
Department: Manufacturing / Operations
Position Overview:
The Site Head will be responsible for the overall management and operations of the API manufacturing site, ensuring safe, compliant, cost-effective, and efficient production. This includes overseeing production, engineering, EHS, QA/QC, regulatory compliance, supply chain, and administration.
Key Responsibilities:
1. Strategic Leadership:
- Lead the API manufacturing site in alignment with the organization’s strategic objectives.
- Drive operational excellence, continuous improvement, and lean manufacturing practices.
- Ensure the site meets short- and long-term business goals (capacity, cost, quality, and compliance).
2. Operational Management:
- Oversee all day-to-day activities related to production, quality, engineering, EHS, and logistics.
- Ensure timely and efficient manufacturing of APIs with adherence to cGMP standards.
- Manage plant budgets, resource planning, and cost controls.
3. Quality & Compliance:
- Ensure full compliance with regulatory standards (USFDA, EUGMP, WHO, etc.).
- Oversee implementation and maintenance of robust quality systems.
- Facilitate regulatory audits, inspections, and customer audits.
4. Safety & Environment:
- Promote a culture of safety and ensure compliance with EHS policies and local environmental regulations.
- Implement robust systems for risk assessment, hazard management, and waste handling.
5. People Management:
- Build and lead a high-performing, motivated team.
- Develop talent, succession planning, and drive employee engagement initiatives.
- Ensure compliance with labor laws and maintain harmonious industrial relations.
6. Stakeholder & Cross-functional Collaboration:
- Work closely with R&D, supply chain, corporate QA, finance, and senior leadership.
- Act as the face of the site for internal and external stakeholders.
Qualifications & Experience:
- Education: B.E./B.Tech in Chemical Engineering
- Experience: 15–25 years in API manufacturing, with at least 5 years in a leadership role.
- Regulatory Exposure: Hands-on experience in handling regulatory inspections like USFDA, EUGMP, PMDA, TGA, etc.
- Skills: Strong leadership, decision-making, communication, project management, and problem-solving skills.
Key Competencies:
- Operational Excellence & Lean Six Sigma
- Strategic & Financial Acumen
- Strong Knowledge of cGMP, ICH, and regulatory requirements
- Change Management & Organizational Development
- Risk Management & Crisis Handling