Cluster Head

Job Title - Cluster Head - Injectable

Experience : 18 to 30 years

Location : Hyderabad/ Vizag

CTC upto 4 crores

This position for one of the leading Pharma company from India.

Position Summary:

- The Cluster Head will be responsible for leading and overseeing the operations of 2-3 Injectable Manufacturing Units, collectively managing 20-30 production lines.

- The role focuses on ensuring efficient manufacturing processes, maintaining the highest quality standards for products destined for US and European markets, and ensuring compliance with all relevant regulatory guidelines, including USFDA and other international bodies.

- A critical component of this role is to build and lead a strong, high-performing team while upholding the principles of Good Manufacturing Practices (GMP) and Quality Compliance.

Key Responsibilities:

Operational Leadership:

- Oversee and manage the end-to-end manufacturing operations of 2-3 injectable units, encompassing 20-30 production lines.

- Drive the achievement of production targets, ensuring optimal utilization of resources and efficient workflow, Project completion etc.

- Implement and champion lean manufacturing principles and continuous improvement initiatives across all units along with OE and HR function.

- Ensure timely delivery of products (OTIF) to meet demand in US, European and other markets.

Quality Assurance & Regulatory Compliance:

- Champion a culture of quality excellence, ensuring all manufacturing processes adhere to national and international regulatory standards- USFDA

- Lead and manage all regulatory audits (including USFDA) and inspections, developing and implementing corrective and preventative actions (CAPA) as needed.

- Collaborate closely with Quality Assurance, Quality Control, and Regulatory Affairs teams to maintain the highest standards of product quality and compliance.

- Ensure all necessary documentation and records are maintained for regulatory filings and inspections.

Team Leadership & Development:

- Build, lead, mentor, and motivate a large team of plant managers, production supervisors, and manufacturing personnel across the three units.

- Foster a high-performance, collaborative team environment, promoting accountability and continuous professional development.

- Develop and implement training programs to enhance skills and knowledge within the manufacturing teams.

Strategic Planning & Business Growth:

- Contribute to the development and execution of the company's manufacturing strategy, aligning with overall business objectives and growth targets in US and European markets.

- Analyse market trends and competitor activities to identify opportunities and threats related to injectable products.

- Collaborate with R&D and Business Development teams for successful product launches and market expansion.

Financial Management:

- Manage budgets, analyse financial performance, and ensure cost optimization across the cluster's operations. Background - Bachelor's or Master's degree in Pharmacy, Pharmaceutical Science.

Experience:

- Minimum 18-30 years of extensive experience in pharmaceutical manufacturing, with a significant portion in injectable/parenteral product manufacturing.

- Proven experience in managing multi-unit operations and leading large teams.

- Demonstrated experience in handling USFDA and other international regulatory audits, with a strong understanding of compliance requirements for US and European markets.

- Strong background in Good Manufacturing Practices (GMP) and Quality Management Systems (QMS).

- Experience with the technical aspects of manufacturing injectable products (aseptic processing, filling, lyophilization, etc.).

Skills & Competencies:

- Strong leadership, strategic thinking, and decision-making skills.

- Excellent communication, interpersonal, and team-building skills, including the ability to influence and collaborate across various functions.

- In-depth knowledge of pharmaceutical manufacturing processes and regulatory landscapes for US and Europe.

- Strong analytical and problem-solving abilities, with a data-driven approach to decision-making. Commitment to maintaining the highest ethical standards and organizational integrity.