Site Quality Head

Responsibilities

• Provide leadership and oversight for QA, QC, and compliance activities to ensure cGMP compliance and the supply of quality products.
• Set site quality goals, objectives, and strategic direction in alignment with Global Quality Goals.
• Manage and track quality and business metrics to monitor QA and QC compliance activities.
• Prevent regulatory non-compliance through the implementation of corrective and preventive actions (CAPA).
• Lead site continuous improvement initiatives, including lean design and standardization to reduce the cost of poor quality.
• Coach, develop, and mentor direct and indirect reports through performance feedback and training.
• Ensure the site maintains 24/7 inspection readiness for all regulatory and customer audits.
• Oversee the testing and timely release of raw materials, packaging, and finished products.
• Ensure compliance with DEA requirements for controlled substances and validate GxP computerized systems.

Requirements

• Bachelor's Degree in Chemistry, Pharmacy, or a relevant Life Science or Engineering field.
• Minimum of 15 years of experience in pharmaceutical quality management.
• Minimum of 5 years of experience in a leadership or supervisory role.
• Significant experience working with oral solid dosage products.
• Strong knowledge of USFDA 21 CFR Part 11, ICH Guidelines, and DEA regulations.
• Deep understanding of GMP requirements in both domestic and international regulatory environments (USFDA, MHRA, EU GMP, PMDA).
• Proven ability to lead, manage, and motivate diverse teams within an international matrixed organization.

About the Company

Ohm Laboratories Inc (a Sun Pharma company) is a leading pharmaceutical organization dedicated to providing high-quality, safe, and effective medicines to customers and markets worldwide. We foster a culture of innovation, integrity, and quality.