Site Quality Head – Sterile / Injectables

Location: Ahmedabad, Gujarat

Industry: Pharmaceutical Manufacturing

Organization Overview :

One of world's largest Infusion & Injectable Company, having a State-of-the art manufacturing facility spread over 550 acres of land at Ahmedabad. It has global operation in more than 100 countries and associated with the healthcare segment since over last 30 years.

Job Summary:

We are seeking an experienced and dynamic Site Quality Head for a leading pharmaceutical manufacturing organization specializing in Sterile and Injectable products. The role will be responsible for leading the overall Quality function including Quality Assurance, Quality Control, and Microbiology while ensuring compliance with global regulatory standards.

Key Responsibilities:

• Lead and manage end-to-end Quality Systems including QA, QC, and Microbiology functions

• Ensure compliance with global regulatory standards such as EU, TGA, PICS, ANVISA, and MHRA

• Drive implementation and continuous improvement of Quality Management Systems and GMP practices

• Handle CAPA management, deviations, non-conformance investigations, and risk management systems

• Oversee Quality Control laboratories, testing procedures, sampling processes, and stability programs

• Ensure regulatory readiness and successful audit management for international agencies

• Collaborate with cross-functional teams to maintain product quality and operational excellence

• Mentor and develop quality teams to enhance technical competency and performance

• Promote a strong culture of quality and compliance across the organization

Candidate Requirements:

• 20–25 years of experience in the pharmaceutical industry

• Strong experience in Sterile / Injectable manufacturing is mandatory

• Deep understanding of GMP, global regulatory requirements, and quality systems

• Proven leadership experience managing large quality teams and operations

• Strong analytical, problem-solving, and stakeholder management skills

Qualification:

• B.Pharm / M.Pharm / M.Sc

Preferred Experience:

• Exposure to regulated markets and international audits

• Experience in handling large-scale sterile manufacturing operations

Interested candidates may apply through LinkedIn or connect directly at [Confidential Information] for a confidential discussion.