Development Quality Assurance

Meril · Gujarat, India

Senior Manager / Manager - Development Quality Assurance (DQA)

Location: Vapi, Gujarat

Experience: 10 -15 Years

Job Summary

We are seeking an experienced Senior Manager / Manager - Development Quality Assurance (DQA) to establish, maintain, and continuously improve the Development Quality Assurance (DQA) system supporting Research & Development activities. The ideal candidate should have strong expertise in Biologics or Cell & Gene Therapy (CGT), with extensive experience in quality systems, regulatory compliance, data integrity, and quality oversight across the product development lifecycle.

Key Responsibilities:

• Prepare, review, revise, and periodically update Quality Assurance SOPs, templates, formats, and other controlled quality documents supporting R&D activities.
• Establish, implement, maintain, and continuously improve the Development Quality Assurance (DQA) system.
• Develop and implement quality procedures supporting process development, analytical development, formulation development, technology transfer, process characterization, and stability studies.
• Review R&D documentation, including SOPs, Work Instructions (WIs), Equipment Operating Procedures (EOPs), specifications, protocols, reports, technical documents, process and analytical development records, method qualification, method transfer, and technology transfer documentation.
• Provide independent quality oversight to ensure compliance with approved procedures, Good Documentation Practices (GDP), ALCOA+ principles, internal quality standards, and applicable regulatory requirements.
• Ensure quality compliance across all product development activities, including process development, analytical method development, validation, qualification, technology transfer, scale-up studies, engineering batches, and stability programs.
• Review laboratory notebooks, electronic laboratory records, worksheets, raw data, chromatograms, calculations, instrument printouts, and supporting documentation for accuracy, completeness, traceability, and compliance.
• Oversee Quality Management System (QMS) activities, including change controls, deviations, investigations, CAPAs, risk assessments, document revisions, and effectiveness verification.
• Participate in investigations related to development deviations, OOS, OOT, documentation errors, and process-related issues while ensuring effective corrective and preventive actions.
• Assess quality and regulatory impact of proposed changes through the change management process.
• Plan, coordinate, and conduct internal quality audits of R&D laboratories and development functions.
• Prepare audit reports, communicate observations, monitor CAPA implementation, and ensure timely closure of audit findings.
• Collaborate with cross-functional R&D teams to ensure effective implementation of quality systems throughout product development.
• Support technology transfer activities by reviewing protocols, reports, risk assessments, and transfer packages.
• Promote a strong quality culture by providing guidance on documentation practices, data integrity, quality risk management, and regulatory compliance.

Required Qualifications:

• Master's Degree in Life Sciences or a related discipline.
• 10-15 years of experience in Development Quality Assurance within the pharmaceutical or biotechnology industry.
• Mandatory experience in Biologics or Cell & Gene Therapy (CGT).
• Strong knowledge of Quality Management Systems (QMS), Good Documentation Practices (GDP), ALCOA+ data integrity principles, and applicable global regulatory requirements.
• Hands-on experience in quality oversight of product development, analytical development, process development, technology transfer, and stability studies.
• Experience in investigations, CAPA management, change control, internal audits, and risk assessments.
• Excellent communication, documentation, problem-solving, and stakeholder management skills.

Preferred Skills

• Strong understanding of regulatory expectations governing biologics and Cell & Gene Therapy product development.
• Experience working in cross-functional R&D environments.
• Excellent leadership, collaboration, and decision-making capabilities.
• Commitment to continuous improvement and quality excellence.

If you have the expertise and passion to drive quality throughout the development lifecycle and contribute to innovative biologics or Cell & Gene Therapy programs, we invite you to apply and become part of our growing team.