Senior Manager / Manager – Development Quality Assurance

About the Role

Meril is looking for a Senior Manager or Manager specializing in Development Quality Assurance (DQA) to be based on-site at Vapi, Gujarat. This role operates within the Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing sectors. The primary focus is to establish, uphold, and enhance the DQA system that supports Research & Development efforts, particularly for Biologics or Cell & Gene Therapy (CGT) products.

Responsibilities

• Develop, review, and update Quality Assurance SOPs, templates, and controlled documents supporting R&D functions.
• Implement and improve Development Quality Assurance systems applicable to R&D operations.
• Design and execute quality procedures for various development stages including process, analytical, formulation development, technology transfer, process characterization, and stability testing.
• Evaluate documentation such as SOPs, work instructions, equipment protocols, specifications, and technical reports to ensure compliance and accuracy.
• Provide independent quality oversight guaranteeing adherence to Good Documentation Practices (GDP), ALCOA+ data integrity principles, internal standards, and regulatory guidelines.
• Maintain quality compliance for process and analytical development, validation, qualification, technology transfers, scale-ups, engineering batches, and stability programs.
• Review laboratory notebooks, electronic records, raw data, chromatograms, and other analytical documents for completeness and traceability.
• Manage Quality Management System tasks including change controls, deviations, investigations, CAPAs, risk assessment, document revisions, and efficacy checks.
• Conduct investigations into deviations, OOS/OOT results, documentation discrepancies, and process-related issues, ensuring corrective/preventive actions are effective.
• Evaluate the quality and regulatory implications of proposed changes using change management systems.
• Plan and perform internal quality audits within R&D labs and functions, prepare reports, issue communications on findings, and monitor CAPA closures.
• Collaborate with cross-functional R&D teams to foster quality systems integration throughout product development.
• Support technology transfer processes through review of protocols, reports, risk assessments, and transfer documentation.
• Champion a robust quality culture by guiding on documentation excellence, data integrity, risk management, and regulatory adherence.

Qualifications and Experience

• Master's degree in Life Sciences or related fields.
• 10 to 15 years of relevant Development Quality Assurance experience in pharmaceutical or biotech industries.
• Mandatory expertise in Biologics or Cell & Gene Therapy (CGT) development.
• Strong proficiency with Quality Management Systems (QMS), Good Documentation Practices (GDP), ALCOA+ integrity principles, and global regulatory standards.
• Practical experience in quality oversight covering product/process development stages and stability studies.
• Expertise in investigations, CAPA handling, change management, audits, and risk evaluations.
• Excellent skills in communication, documentation, problem resolution, and stakeholder coordination.

Preferred Competencies

• Deep knowledge of regulatory frameworks specific to biologics and CGT product development.
• Experience collaborating within cross-functional R&D teams.
• Strong leadership, decision-making, and teamwork capabilities.
• Dedication to continuous quality enhancement.