QA & RA Manager

Quality Assurance (QA) Management:

• Develop and implement the quality assurance strategy and policies to ensure compliance with regulatory requirements and industry standards.
• Oversee the QA functions, including the development, implementation, and maintenance of quality management systems (QMS).
• Ensure that all manufacturing processes and products meet the required quality standards through regular audits, inspections, and reviews.
• Lead investigations into quality issues, deviations, and non-conformances, ensuring timely resolution and implementation of corrective and preventive actions (CAPAs).

Quality Control (QC) Oversight:

• Oversee the QC departments activities, including the testing of raw materials, in-process materials, and finished products.
• Ensure the QC lab operates in compliance with regulatory requirements and maintains high standards of accuracy, precision, and reliability.
• Develop and implement QC procedures and protocols, ensuring they are in line with industry best practices and regulatory guidelines.
• Monitor and evaluate QC performance metrics, ensuring timely and accurate reporting of test results.

Regulatory Affairs Management:

• Develop and execute the regulatory strategy for the organization, ensuring compliance with global regulatory requirements (e.g., FDA, EMA, ICH, etc.).
• Prepare and submit regulatory filings, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and marketing authorization applications (MAAs).
• Monitor changes in regulatory requirements and ensure the organizations policies and procedures are updated accordingly.
• Serve as the primary point of contact for regulatory agencies and manage interactions, inspections, and audits.

Team Leadership & Development:

• Coordinate with the QA, and Regulatory Affairs teams, setting clear objectives and performance expectations.