Job Description

This role is responsible for leading and managing quality control operations within a pharmaceutical manufacturing environment, ensuring compliance with established standards and regulatory requirements. The incumbent oversees in-process and final product quality analyses and inspections, interpreting and evaluating results against predetermined specifications to ensure product integrity and patient safety. The position identifies ongoing quality issues, implements preventive measures, and drives continuous improvement initiatives across quality control functions. It manages a team of quality control professionals, providing technical guidance, coaching, and performance oversight to build a high-performing quality control function. The role audits and monitors manufacturing processes and quality control outputs against both internal and regulatory standards to uphold compliance and drive operational excellence. It oversees the testing of random samples of finished goods and ensures conformance with quality specifications and regulatory expectations. The position reports manufacturing process deviations and defects to senior quality leadership and ensures timely resolution of quality issues. It supports the organization's commitment to delivering safe, effective, and compliant pharmaceutical products by building and sustaining a robust quality control capability.

Essential Functions:

• Lead and manage quality control operations to ensure compliance with established specifications and regulatory requirements.

• Oversee in-process and final product quality analyses and inspections, interpreting results against predetermined quality standards.

• Identify ongoing quality issues and implement preventive measures and continuous improvement initiatives across quality control functions.

• Manage and develop a team of quality control professionals, providing technical guidance, coaching, and performance oversight.

• Audit and monitor manufacturing processes and quality control outputs against defined internal and regulatory quality standards.

• Oversee the testing of random samples of finished goods to verify compliance with quality specifications.

• Report manufacturing process deviations and defects to senior quality leadership and ensure timely resolution of quality issues.

• Collaborate with cross-functional teams including manufacturing, regulatory affairs, and quality assurance to address quality challenges.

• Maintain accurate and complete documentation of all quality control activities in compliance with GMP and GLP requirements.

Additional Responsibilities: Education:

• Bachelors Degree (BA/BS) B. Sc. - Required

• Master Degree (MS/MA) M. Sc. - Preferred

Experience:

• 8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses: